Veklury (Remdesivir) Antiviral Treatment Description For 2022
Gilead Sciences, Inc. Veklury® (remdesivir; GS-5734, DESREM, Redyx) is a nucleotide analog with broad-spectrum antiviral activity. Gilead Sciences Veklury inhibits the SARS-CoV-2 RNA-dependent RNA polymerase, essential for viral replication. Veklury is a prodrug that distributes into cells and is metabolized into the pharmacologically active remdesivir triphosphate (RDV-TP). RDV-TP acts as an analog of ATP and competes with it to incorporate nascent viral RNA. It incorporates RDV-TP into developing viral RNA, resulting in delayed chain termination (position i+3) and disrupting SARS-CoV-2 viral RNA replication.
The Company developed remdesivir to treat hepatitis C and was subsequently investigated for Ebola and Marburg viruses. In addition, Gilead announced on Oct. 22, 2020, that the U.S. Food and Drug Administration (FDA) has approved Veklury for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
On Mar. 7, 2021, the European Medicines Agency (EMA) issued marketing approval in the E.U. In addition, the EMA and the European Commission (E.C.) approved a variation to the Conditional Marketing Authorization for Veklury on Dec. 21, 2021, to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. Furthermore, the EMA accepted a modification of an agreed pediatric investigation plan for Veklury (EMEA-002826-PIP01-20-M02) on Aug. 9, 2021. On Mar. 15, 2022, the EMA published updated clinical information. On Jun. 8, 2022, the EMA published a list of critical authorized medicines, including Veklury, for the COVID-19 public health emergency. On Jul. 22, 2022, the EMA's committee recommended granting full marketing authorization to Veklury (remdesivir) following the submission of data by the marketing authorization holder to fulfill the last outstanding specific obligation.
In the EU and EEA, Veklury is the only antiviral indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen. In December 2021, the European Commission expanded the indication for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
On Jan. 21, 2022, the U.S. FDA expanded Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients to treat mild-to-moderate COVID-19. In addition, the FDA confirmed that Vekluery drug interaction studies and other concomitant medications were not conducted in humans. And on Apr. 25, 2022, the FDA expanded the approval to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing; Hospitalized or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
On May 2, 2022, the peer-review journal The Lancet reported the final results of the Solidarity phase 3 study and meta-analyses - Interpretation: Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated. Among other hospitalized patients, it has a negligible impact on death or progression to ventilation (or both).
And on Jun. 15, 2022, the U.S. CDC published: Interim Clinical Considerations for COVID-19 Treatment in Outpatients. Veklury (Remdesivir): The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single-dose clear glass vials in powder form and reconstituted at the use site. ChemSpider ID: 58827832; ChEMBL Id: 4065616; Accession Number: DB14761 Formula: C27H35N6O8P; Molar mass: 602.585 g/mol; PubChem CID: 121304016. Updated fact sheets for healthcare providers and parents/caregivers and FAQs. Billing codes for the U.S. are located at this CMS link.
On Sept. 15, 2022, Gilead announced updates to the WHO Therapeutics and COVID-19: living guideline, conditionally recommends Veklury® (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization.
Veklury is approved or authorized for use in approximately 50 countries worldwide. In addition, Veklury and generic remdesivir have been made available to more than 10 million patients worldwide, including 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. The EMA published a Clinical Update - EMEA/H/C/005622/II/0034/G - on August 26, 2022:
Gilead Science, Inc. (Nasdaq: GILD) is located in Foster City, CA, 94404.
The list price for Vevkury (remdesivir) is $520 per vial. Veklury sales decreased by 52% in the third quarter of 2022 compared to the same period in 2021. Additional antiviral, antibody, or vaccine price information is posted at InstantRx™.
Gilead Sciences announced in July 2022, that the Committee for Medicinal Products for Human Use of the European Commission adopted a positive opinion on the fulfillment of the last specific obligation and recommended the granting of Marketing Authorization for Veklury® (remdesivir) that is no longer subject to specific obligations.
Veklury Omicron Sublineages
On Aug. 16, 2022, Gilead confirmed no major genetic changes had been identified in any of the known SARS-CoV-2 variants of concern and variants of interest that would significantly alter the viral RNA polymerase targeted by Veklury. As of Aug. 4, 2022, the U.S. NIH's OpenData Portal reports Veklury's in vitro Therapeutic Activity against the Omicron B.1.1.529 variant. In addition, the U.S. CDC and Scripts update coronavirus variant information in this Tracker App. And the WHO publishes Tracking SARS-CoV-2 Variants on this webpage.
Gilead released non-peer-reviewed data on Feb. 10, 2022, demonstrating the in vitro activity of Veklury against ten SARS-CoV-2 variants, including Omicron.
Gilead announced that Veklury (remdesivir) is available to hospital and qualified nonhospital outpatient facilities. These entities should contact ASD at [email protected] or 1-800-746-6273 to order Veklury for nonhospital use.
Gilead Sciences and the European Commission signed a new joint procurement agreement on July 19, 2022, that will ensure continued rapid and equitable access to Veklury® (remdesivir) for participating Member States across the European Union and European Economic Area.
Veklury was the first antiviral treatment for COVID-19 to receive FDA approval. In 2009, Remdesivir research programs were underway in hepatitis C and respiratory syncytial virus. In the fall of 2015, Gilead Sciences applied for two patents for remdesivir, one for combating coronaviruses, including SARS and MERS. And another for filoviruses, the family of pathogens that includes Ebola. Gilead Science first received a patent (US9724360B2) for the drug (remdesivir) to treat Ebola in 2017.
Veklury Side Effects
The U.S. FDA says 'possible side effects include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, even addition, due shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.'
The EMA says the overall potential for drug interactions is currently unknown; patients should remain under close observation during the days of remdesivir administration. In addition, due to antagonism observed in vitro, concomitant use of remdesivir with chloroquine phosphate or hydroxychloroquine sulfate is not recommended. The Assessment Report EMA/2138/2022 was updated on Dec. 16, 2021.
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or its components. Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following the administration of Veklury. The most common adverse reaction (≥5% of all grades) was nausea. The most common lab abnormalities (≥5% of all grades) were increases in ALT and AST. And drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans, confirms the U.S. FDA.
There is limited data on remdesivir use in pregnant women, says the EMA. Pregnancy: There is insufficient human data on using Veklury during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. Veklury should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
Lactation: It is not known whether Veklury can pass into breast milk. Breastfeeding women with COVID-19 should follow clinical guidelines to avoid exposing their infant to COVID-19. Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions from the drug in breast-feeding infants, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from remdesivir therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
A 3-day course of IV remdesivir initiated within 7 days of symptom onset is the second preferred treatment option after Paxlovid for adults, and pediatric patients says the U.S. CDC. In the U.S., Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days and older and weighing at least 3 kg) who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death, as of April 25, 2022. "The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability, and efficacy profile of this therapy, which has remained the foundational antiviral for COVID-19 treatment," said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences. "Effective and tolerable options for children require our best science and a dedicated focus."
The latest clinical trial data demonstrate that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery. Overall, no new safety findings for Veklury were noted, and 85% of patients showed clinical improvement based on the clinical ordinal scale, and the recovery rate was 83% at the last assessment (N=53).
Dosage: Veklury (remdesivir 100 mg for injection) is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) to treat COVID-19 requiring hospitalization. For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes. Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
For non-hospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression related to the Omicron variant, the U.S. NIH Panel recommended on January 19, 2022, Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV daily on Days 2 and 3, initiated as soon as possible and within seven days of symptom onset in those aged ≥12 years and weighing ≥40 kg (BIIa).
Testing before and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing before initiating Veklury and during use as clinically appropriate. Renal impairment: Veklury is not recommended in individuals with eGFR <30 mL/min.
In May 2020, Gilead announced non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India, and Pakistan to expand the supply of remdesivir further. The agreements allow the companies – Cipla Ltd.; Dr. Reddy's Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle-income countries and several upper-middle- and high-income countries facing significant healthcare access obstacles.
Veklury IV Delivery
On December 22, 2021, the Company announced participants receiving Veklury IV treatment in the randomized, double-blind, placebo-controlled phase 3 trial had an 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by Day 28 and an 81% reduction in the risk for the composite secondary endpoint of COVID-19-related medical visits due to COVID-19 or all-cause death by Day 28 compared to placebo. There was no difference observed in nasopharyngeal SARS-CoV-2 viral load up to Day 7 between groups, indicating that upper respiratory viral loads do not reliably predict treatment outcomes in COVID-19. No deaths were observed in either arm of the study by Day 28.
The Veklury (remdesivir) FDA approval includes two presentations: remdesivir for injection, 100 milligrams (mg), a sterile, preservative-free lyophilized powder, and remdesivir injection, 100 mg/20 milliliters (mL) (5 mg/mL), a sterile, preservative-free solution. The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single-dose clear glass vials in powder form and reconstituted at the use site. The U.S. FDA issued a caution on February 4, 2021, against compounding remdesivir drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Drug products compounded by outsourcing facilities from bulk remdesivir do not qualify for the exemptions under section 503B of the FD&C Act unless remdesivir is added to the 503B bulks list, or the approved remdesivir product appears on FDA's drug shortage list.
Veklury CPT Codes
The Centers for Medicare & Medicaid Services assigned a new HCPCS code of J0248 for 3-day IV infusions of Veklury in the outpatient setting to help facilitate payment and simplify claims documentation and processing for Medicare Part B patients.
India-based Zydus announced on March 24, 2021, that its version of Remdesivir, Remdac, is more affordable at Rs. 899 for a 100 mg lyophilized injection. Remdac was launched in August 2020 at Rs. 2800.
October 27, 2022 - Veklury sales decreased by 52% to $925 million for the third quarter of 2022 compared to the same period in 2021, primarily driven by lower rates of COVID-19-related hospitalizations compared to the third quarter of 2021. Veklury revenue generally reflects COVID-19-related rates and severity of infections and hospitalizations, as well as the availability, uptake, and effectiveness of vaccinations and alternative treatments for COVID-19.
August 2, 2022 - Gilead reported sales decreased by 46% to $445 million for 2Q2022 compared to the same period in 2021.
April 28, 2022 - Gilead reported first-quarter 2022 sales on Veklury: which increased by 5% to $1.5 billion for the first quarter of 2022 compared to the same period in 2021.
February 1, 2022 - In the fourth quarter of 2021, Veklury produced $5.6 billion in revenue for 2021.
Veklury News For 2020 - 2022
November 22, 2022 - Study: Real-world evidence of novel treatments for COVID-19 on mortality: a nationwide comparative cohort study of hospitalized patients in the 1st, 2nd, 3rd, and 4th wave in the Netherlands. Conclusions - Both remdesivir and corticosteroids were associated with better outcomes in ward patients with COVID-19.
September 15, 2022 - The WHO conditional recommendation for Veklury’s use in the treatment of patients with severe COVID-19 is mainly driven by the final results of the WHO-sponsored SOLIDARITY study, which showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to standard of care (RR: 0.83; 95% CI: 0.75–0.93).
August 29, 2022 - The JAMA Network published a Research Letter: Remdesivir in Patients With Severe Kidney Dysfunction. In patients with eGFR less than 30 mL/min/1.73 m2 at baseline who received remdesivir in a limited study, there was no increased risk of transaminitis or toxic kidney effects at day 5. There was also no significant difference in the need for invasive mechanical ventilation or new dialysis, or mortality.
August 16, 2022 - Gilead conducted in vitro analyses of Veklury activity against Omicron subvariants BA.2.12.1, BA.4, and BA.5, results continued to confirm that Veklury retains antiviral activity against all Omicron subvariants analyzed to date.
July 19, 2022 - New Agreement Enables The Rapid and Equitable Access to Veklury for COVID-19 Patients in EU and EEA Countries.
June 15, 2022 - The U.S. CDC published: Interim Clinical Considerations for COVID-19 Treatment in Outpatients.
May 2, 2022 - The peer-review journal The Lancet published the final results of Solidarity and meta-analyses of mortality in all relevant trials to date. Interpretation: Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated. Among other hospitalized patients, it has a small effect on death or progression to ventilation (or both).
May 2, 2022 - The Lancet published an Editorial: When and which patients should receive remdesivir?
April 25, 2022 - Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, stated in a press release, "Today's approval of the first COVID-19 therapeutic for this (pediatric) population demonstrates the agency's commitment to that need." This approval is supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults.
April 21, 2022 - The Company announced an updated WHO guideline recognizes the important role of Veklury in helping people at high risk of COVID-19 disease progression but does not currently reflect the broad body of evidence supporting Veklury's effectiveness across a broad spectrum of disease severity, as do several other global treatment guidelines. We anticipate the WHO will continue to consider robust evidence from multiple randomized, controlled trials, including ACTT-1 and independent meta-analysis, which demonstrate the efficacy of Veklury in later-stage COVID-19 disease and update their recommendation for patients with a severe or critical illness.
March 31, 2022 - A non-peer-reviewed preprint published concluded that Remdesivir use for treating hospitalized patients with COVID-19 was not associated with clinical improvement at day 15. The large phase 3 clinical study observed hospitalized patients in Europe from March 2020 to January 2021.
March 17, 2022 - The journal Nature Communications published: De novo emergence of a remdesivir resistance mutation during treatment of persistent SARS-CoV-2 infection in an immunocompromised patient: a case report. We present a case of an immunocompromised patient with acquired B-cell deficiency who developed an indolent, protracted course of SARS-CoV-2 infection. Remdesivir therapy alleviated symptoms and produced a transient virologic response, but her course was complicated by a recrudescence of high-grade viral shedding. Whole-genome sequencing identified a mutation, E802D, in the nsp12 RNA-dependent RNA polymerase, which was absent in pre-treatment specimens. Our findings underscore the importance of immunocompromised hosts with uncontrolled viral replication as a source of genetic diversification and selection of mutations that may potentially impart adverse consequences for antiviral therapy.
March 14, 2022 - The ACP journal published - A major update to an American College of Physicians' living systematic review has been corrected as follows: A 10-day course of remdesivir may result in a small reduction in median time to clinical improvement versus control (placebo or standard care), reflecting a low certainty of evidence.
March 3, 2022 - The WHO published its 9th version of the Therapeutics and COVID-19: living guideline, which includes an UPDATE: conditional recommendation against remdesivir in hospitalized patients with COVID-19.
March 1, 2022 - Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 2, Update Alert 3). A previously reported post hoc analysis assessing variation in disease severity between a 5 and a 10-day course suggested that continued treatment through 10 days resulted in lower mortality among patients who progressed to requiring invasive ventilation or ECMO at day 5. However, no improvement was observed in mortality among patients who were receiving noninvasive positive-pressure ventilation, receiving high- or low-flow oxygen, or was breathing ambient air.
February 11, 2022 - Gilead Sciences, Inc. announced new data from an interim analysis of its ongoing, Phase 2/3 single-arm, open-label study of Veklury in pediatric patients hospitalized with COVID-19 with ages ranging from 28 days to less than 18 years. Overall, no new safety findings for Veklury were noted, and 85% of patients showed clinical improvement based on the clinical ordinal scale and the recovery rate was 83% at the last assessment (N=53).
February 11, 2022 - Gilead released data from a non-peer-reviewed study demonstrating the in vitro activity of Veklury® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Previous study results confirmed Veklury's antiviral activity against Alpha, Beta, Gamma, Delta, and Omicron.
February 7, 2022 - NPR reported 'Why remdesivir, a highly effective COVID treatment, is the last resort for providers.' U.S. federal agencies now recommend remdesivir as one of four options for treating early COVID-19.
February 4, 2022 - The California Department of Public Health issued an alert regarding supplies of recommended outpatient therapeutics, with the exception of Remdesivir, which remains in limited supply.
January 27, 2022 - MedPage Today conducted a fact check of Dr. Marik's recent statement and could not find any evidence in the scientific literature that showed remdesivir was associated with an increased risk of death.
January 21, 2022 - Gilead Sciences, Inc. announced that the U.S. FDA had granted expedited approval of a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The FDA sNDA approval, pediatric EUA expansion, and recently updated National Institutes of Health (NIH) Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings
January 21, 2022 - The Union health ministry Directorate General of Health Services discourages remdesivir for non-adults in India.
January 21, 2022 - The U.S. FDA's Patrizia Cavazzoni, M.D., stated: "Today's actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers."
January 19, 2022 - The U.S. NIH published an updated version of the COVID-19 Treatment Guidelines Panel statement. This version addresses that the B.1.1.529 (Omicron) variant is now dominant SARS-CoV-2 in the U.S.
January 17, 2022 - A randomized phase 2 control clinical trial published by the Canadian Medical Association Journal shows remdesivir reduces the use of mechanical ventilation by almost half for patients hospitalized with COVID-19. Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes, such as the need for mechanical ventilation.
January 7, 2022 - The Centers for Medicare & Medicaid Services issued a new Healthcare Common Procedure Coding System code for VEKLURY (remdesivir) when administered in the outpatient setting: Long descriptor: Injection, remdesivir, 1 mg; Short descriptor: Inj, remdesivir, 1 mg.
December 30, 2021 - The U.S. NIH issued revised COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19.
December 30, 2021 - Reuters reported the Russian government extended the approval for drugmaker Pharmasyntez to produce a generic version of remdesivir without a patent for one year.
December 22, 2021 - Gilead Sciences, Inc. announced full results from a Phase 3 investigational study evaluating the efficacy and safety of a three-day course of Veklury for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. The results have been published today in the New England Journal of Medicine and have been submitted to the Food and Drug Administration for the potential use of Veklury in earlier stages of the disease, including prior to hospitalization.
December 21, 2021 - Gilead Sciences, Inc. announced that the European Commission has approved a variation to the Conditional Marketing Authorization for Veklury to include adults in the E.U. who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
December 17, 2021 - The EMA stated - Veklury (remdesivir), an antiviral medicine, has been authorized for the treatment of patients with COVID-19 who have pneumonia and require supplemental oxygen since July 2020. In addition, the CHMP recommended including the treatment of adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 to its indication.
December 3, 2021 - Gilead Sciences Inc. announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead received a customer complaint, confirmed by the firm's investigation, of the presence of glass particulates. The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material.
November 11, 2021 - The EMA published an updated Veklury 100 mg powder for concentrate for solution for infusion product overview.
November 2, 2021 - A phase 3 clinical trial found that a 3-day course of intravenous Veklury in outpatients at high risk of progression to severe COVID-19 significantly reduced the risk of hospitalization by 87% versus placebo.
October 26, 2021 - V.A. Study Questions Value of Remdesivir in Hospitalized COVID-19 Patients.
October 19, 2021 - Gilead announced that the Company would donate 100,000 vials of Veklury to help address the recent surge of COVID-19 cases in Indonesia and 3,000 vials to Armenia.
September 22, 2021 - Gilead Sciences, Inc. announced positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury® (remdesivir) for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.
September 14, 2021 - The Lancet published the results from a phase 3, open-label, adaptive, multicentre, randomized, controlled trial conducted in 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg. Interpretation: No clinical benefit was observed from the use of remdesivir in patients admitted to the hospital for COVID-19, were symptomatic for more than seven days, and required oxygen support. The related commentary concluded: remdesivir might have a clinically meaningful benefit in well-selected patients that deserves further exploration. It will be essential to compare its clinical effects with those of approved monoclonal antibodies. However, remdesivir's potential benefit from steroids and other approved immunomodulators such as baricitinib and tocilizumab are highly uncertain. As findings from DisCoVeRy show an absence of effect on late clinical status and mortality, there is no reason to advocate remdesivir use outside of clinical trials.
August 17, 2021 - The Annals of Internal Medicine published a Retrospective Cohort Study - Use of Remdesivir and Dexamethasone Among Adults Hospitalized With COVID-19 in the USA. The use of remdesivir and dexamethasone varied across health systems, suggesting variation in patient case-mix, drug access, treatment protocols, and quality of care.
August 3, 2021 - Indian's Union health minister Mansukh Mandaviya stated that the production capacity of Remdesivir (Veklury) in India had increased from 38.8 lakh vials per month mid-April to 122.49 lakh vials per month in June 2021. To substantially augment the production of Remdesivir in India, the Drugs Controller General of India had granted expeditious approval to 40 new manufacturing sites of licensed manufacturers of the drug,
July 14, 2021 - JAMA published an Original Investigation: Association of Remdesivir Treatment With Survival and Length of Hospital Stay Among U.S. Veterans Hospitalized With COVID-19. In this cohort study of 2,344 US veterans hospitalized with COVID-19, remdesivir therapy was not associated with improved 30-day survival but with a significant increase in median time to hospital discharge. The findings suggest that routine use of remdesivir may be related to increased use of hospital beds but not improved survival. "These findings suggest that clinicians may not have discharged some patients who were receiving remdesivir until they completed a 5-day course."
July 13, 2021 - The Annal of Internal Medicine published Original Research: Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19.
June 21, 2021 - Gilead Sciences, Inc. announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury® (remdesivir).
June 15, 2021 - The Annals of Internal Medicine published the third update for our living rapid review on remdesivir for adults with COVID-19. 'Our original conclusions about certainty and strength of evidence of remdesivir for adults with COVID-19 remain unchanged.'
May 4, 2021 - India Union Minister for state chemical and Fertiliser Mansukh Mandaviya said that the production of Remdesivir injection has increased to 1.05 crore monthly.
April 26, 2021 - Gilead Sciences, Inc. announced that in response to the rapid increase in COVID-19 cases in India, the Company is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities, and the donation of active pharmaceutical ingredient to scale up production of remdesivir rapidly. Remdesivir is approved in India for restricted emergency use.
April 15, 2021 - The National Institute of Allergy and Infectious Diseases announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial was closed to enrollment because the study met pre-defined futility criteria regimen studied is likely significantly better than the other.
April 12, 2021 - Gilead has decided to stop its Phase 3 Veklury® (remdesivir) intravenous study in high-risk non-hospitalized patients with COVID-19. Based on the evolution of the COVID-19 landscape and challenges in enrolling this study, we no longer believe that developing a multiple-day IV infusion treatment that requires administration in a healthcare setting addresses an unmet need for non-hospitalized patients.
March 31, 2021 - The U.S. government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report. The GAO reviewed federal contributions to developing remdesivir and related agency patent rights. As of Dec. 2020, federal funding for preclinical studies and clinical trials involving remdesivir totaled about $162 million.
March 24, 2021 - The JAMA published a multicenter comparative effectiveness research study that included 2,483 consecutive admissions with a high proportion of non-White individuals. Treatment with remdesivir was associated with more rapid clinical improvement than no remdesivir receipt in the propensity score-matched controls. The addition of corticosteroids to remdesivir was not associated with improved time to death.
February 17, 2021 - A new study funded by the U.S. National Institutes of Health will evaluate the effects of remdesivir in pregnant women who have been prescribed the drug to treat COVID-19. The study, conducted at 17 sites in the continental USA and Puerto Rico, aims to determine how pregnant women metabolize the drug and any potential side effects.
February 12, 2021 - The European Medicines Agency (EMA) concluded following a safety review: Remdesivir (Veklury) is not associated with acute kidney injury. Veklury received conditional marketing authorization from the EMA and is indicated for the treatment of COVID-19 in adults and adolescents (12 years or more) with pneumonia who require supplemental oxygen.
February 9, 2021 - The Annals of Internal Medicine published 'Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 2).' Our current understanding of COVID-19 progression is that patients who are admitted on mechanical ventilation or ECMO have likely progressed beyond the viral stage of the illness to the inflammatory phase and are less likely to improve from antivirals; hence, it is essential to avoid any additional toxicity from remdesivir, unless there is evidence for potential benefit.
February 4, 2021 - Gilead Sciences, Inc. announced its fourth quarter and full-year 2020. Remdesivir, sold under the brand name Veklury, has been used in around half of the hospitalized patients with COVID-19 in the U.S. The drug, which ranges in price from $2,340 to $3,120 for a five-day treatment course, produced approximately $1.9 billion in Gilead sales in the fourth quarter of 2020.
February 4, 2021 - The U.S. FDA reminded health care providers that compounded drugs are not FDA-approved and are not evaluated by FDA for safety, effectiveness, or quality. Compounded medications should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
January 22, 2021 - Local media reported Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the U.K. and South Africa. According to the U.S. biopharma company, genetic analyses of publicly available sequences for the latest variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn't affect the way Veklury (remdesivir) works.
January 1, 2021 - One of the four persons admitted to Lok Nayak Hospital with Covid-19 caused by the UK-variety mutated strain of the novel coronavirus is administered antiviral drug remdesivir.
December 30, 2020 - Researchers at the University of Cincinnati say an antiviral drug used to treat Covid-19 is being used too indiscriminately on patients hospitalized with the virus. As a result, physicians who opt to use the treatment should do so with caution.
December 11, 2020 - The NEJM published an original article: Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating clinical status improvement among patients with COVID-19, notably those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had time to recover ten days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group.
December 2, 2020 - An editorial published by the NEJM found 'The approval of remdesivir (Veklury) marked an important step toward addressing the needs of patients with COVID-19. But, the absence of a demonstrated survival benefit highlights the need for continued therapeutic development.'
November 22, 2020 - The Infectious Diseases Society of America stated it would continue to recommend remdesivir (Veklury) for patients with severe COVID-19, in version 3.5.0., which included ACCT-1 trial results that showed an improved time to recovery in hospitalized patients.
November 20, 2020 - The WHO announced a conditional recommendation against the use of remdesivir (Veklury) in hospitalized patients, regardless of disease severity.
November 19, 2020 - In a phase II study conducted in West Africa, last updated on September 30, 2020, Veklury (GS-5734) reduced Ebola viral matter in the semen of male survivors, according to Dehkontee Gayedyu-Dennis, MD, of the Partnership for Research on Vaccines and Infectious Diseases in Paynesville, Liberia, speaking at the virtual meeting of the American Society of Tropical Medicine & Hygiene.
November 5, 2020 - The NEJM published 'Remdesivir for the Treatment of Covid-19 — Final Report.' Our data show that remdesivir was superior to placebo in shortening recovery in adults hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705)
November 3, 2020 - Reuters reported 'Germany has requested around 5% of the supply of Veklury (remdesivir) under a 6-month European Union supply deal with Gilead.
October 22, 2020 - The U.S. FDA Approved the antiviral drug Veklury® (remdesivir) to treat patients with COVID-19 requiring hospitalization.
September 9, 2020 - Dr. Reddy's Laboratories announces the launch of Redyx in India. The launch is part of the licensing agreement with Gilead Sciences, Inc. that grants Dr. Reddy's rights to register, manufacture and sell Remdesivir, a potential treatment for COVID-19, in 127 countries, including India.
August 28, 2020 - The U.S. FDA broadened the existing emergency use authorization scope for Veklury. As a result, Gilead Sciences's expanded the Emergency Use Authorization (EUA), enabling the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
August 21, 2020 - JAMA: Effect of Remdesivir vs. Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19. Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant clinical status difference from standard care at 11 days after treatment initiation. Patients randomized to a 5-day course of remdesivir had a statistically significant clinical status difference than usual care, but the difference was uncertain clinical importance.
July 24, 2020 - Remdesivir was linked to significantly greater recovery and a 62% lower death rate by day 14 versus standard treatment in hospitalized adults with severe COVID-19 disease.
July 6, 2020 - Mylan N.V. announced that India's Drug Controller General had approved its remdesivir 100 mg/vial for restricted emergency use in India's COVID-19 patients. The drug is approved to treat suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe disease presentations. The drug will be launched under the brand name DESREM™ in India.
June 29, 2020 - The U.S. Department of Health and Human Services announced an agreement to secure ample supplies of the drug remdesivir for the United States from Gilead Sciences through September, allowing American hospitals to purchase the drug in amounts allocated HHS and state health departments. HHS has secured more than 500,000 treatment courses for American hospitals through September 2020.
June 25, 2020 - The European Medicines Agency (EMA) said its human medicines committee (CHMP) recommended conditionally approving the drug for adults and adolescents from 12 years of age who also suffer from pneumonia and require oxygen support. This European Union conditional marketing authorization allows treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side effects are available.
June 15, 2020 - FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use.
June 1, 2020 - Gilead announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study demonstrated that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 than those in the standard care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance.
May 1, 2020 - The U.S. FDA issued an emergency use authorization for the investigational antiviral drug remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
April 29, 2020 - Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Preliminary results indicate that patients who received remdesivir had a 31% faster recovery time than placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received a placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).
April 10, 2020 - Gilead Sciences announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. Most patients in this international cohort demonstrated clinical improvement, and no new safety signals were identified with remdesivir treatment. This analysis's detailed results were published today in The New England Journal of Medicine.
February 25, 2020 - A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with COVID-19 began at the University of Nebraska Medical Center in Omaha.
Veklury Clinical Trials
Gilead has initiated various clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. FDA's rapid review and acceptance of Gilead's investigational new drug filing.
The approval of Veklury for use in non-hospitalized patients on January 21, 2022, is supported by a randomized, placebo-controlled phase 3 clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, including hospitalization or death. The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.
On January 17, 2022, the results from the COVID-19: Canadian Arm of the phase 2 SOLIDARITY Trial (CATCO) - 3-arms in a 1:1:1 ratio randomization to either the control arm, consisting of standard supportive care treatment for COVID-19 or remdesivir plus standard supportive care or Interferon-beta-1a plus standard supportive care. Interpretation: Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation.
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting: ClinicalTrials.gov Identifier: NCT04501952 The PINETREE was a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a three-day course of Veklury IV in reducing the rate of hospitalization or all-cause death among non-hospitalized COVID-19 patients at high risk for disease progression.
On March 24, 2021, the Journal of Antimicrobial Chemotherapy reported a meta-analysis of five randomized clinical trials. Remdesivir treatment of hospitalized patients with noncritical COVID-19 was associated with better clinical improvement, shorter recovery, hospital stays, and safety.
A Phase 3 study - NCT04315948 - Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults. Remdesivir will be administered as a 200 mg intravenous loading dose on Day 1, followed by a 100 mg once-daily intravenous maintenance dose for the duration of the hospitalization up to a 10 days total course. Results were published on September 14, 2021.
Topline results from the open-label, Phase 3 SIMPLE trial, reported the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. In addition, more than half of patients in both treatment groups were discharged from the hospital by Day 14.