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Veklury (Remdesivir) Antiviral

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January 20, 2022
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Veklury (Remdesivir) Antiviral Treatment Description

Veklury (remdesivir; GS-5734, DESREM, Redyx) is a nucleotide analog with broad-spectrum antiviral activity. Gilead Sciences' Veklury acts to inhibit the SARS-CoV-2 RNA-dependent RNA polymerase, which is essential for viral replication, says the Company. Veklury (remdesivir) is administered through a vein by intravenous infusion, one time each day for up to 10 days, as determined by your healthcare provider, says Gilead Sciences.

Veklury is a prodrug that distributes into cells where it 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. Incorporating RDV-TP into developing viral RNA results in delayed chain termination (position i+3), disrupting SARS-CoV-2 viral RNA replication.

Gilead Sciences, Inc. announced on October 22, 2020, that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) 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. 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 site of use. 

On March 7, 2021, the European Medicines Agency (EMA) issued marketing approval in the E.U. Furthermore, the EMA issued the acceptance of a modification of an agreed pediatric investigation plan for remdesivir (Veklury) (EMEA-002826-PIP01-20-M02) on August 9, 2021, per Regulation No 1901/2006 of the European Parliament and the Council.

The EMA and the European Commission (EC) approved on December 21, 2021, a variation to the Conditional Marketing Authorization for Veklury® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19 on December 21, 2021. The EC's decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate 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. In addition, as of December 21, 2021, laboratory findings suggest that Veklury will continue to be active against the currently identified variations in the SARS-CoV-2 virus, including the Omicron variant.

On December 22, 2021, the New England Journal of Medicine published a phase 3 clinical study: Veklury (remdesivir) for intravenous (IV) use for the treatment of COVID-19. Finding: Among non-hospitalized patients at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than a placebo.

On December 23, 2021, the U.S. NIH issued a statement providing 'guidance on the use of anti-SARS-CoV-2 mAbs or remdesivir, when the SARS-CoV-2 coronavirus Omicron VOC is the predominant circulating variant.

Veklury (Remdesivir): ChemSpider ID: 58827832; ChEMBL Id: 4065616; Accession Number: DB14761 Formula: C27H35N6O8P; Molar mass: 602.585 g/mol; PubChem CID: 121304016.

Gilead Science, Inc. (Nasdaq: GILD) is located in Foster City, CA 94404.

Veklury (Remdesivir) Antiviral Effectiveness Against Variants (Omicron, B.1.1.529)

As of January 20, 2022, the U.S. NIH's OpenData Portal reports in vitro Therapeutic Activity against the Omicron B.1.1.529 variant. In addition, the U.S. CDC and Scripts publishes updated coronavirus variant information in this Tracker App. And the WHO publishes Tracking SARS-CoV-2 Variants on this webpage.

An initial analysis of genetic information from the Omicron variant suggests that Veklury will continue to be active against the new coronavirus variant. Gilead will conduct laboratory testing to confirm this analysis. As of December 21, 2021, no significant genetic changes have been identified in any known variants of concern that would significantly alter the viral RNA polymerase targeted by Veklury. Veklury's antiviral activity has been tested in vitro against isolates of variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta, and Epsilon.

Veklury (Remdesivir) Antiviral History

In 2009, Remdesivir research programs were underway in hepatitis C and respiratory syncytial virus. In fall 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.

As of May 1, 2020, Veklury (remdesivir) was issued an Emergency Use Authorization in the USA for hospitalized with severe disease. As a result, the FDA authorized the use of Veklury (remdesivir) to treat hospitalized adult and pediatric patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19 disease. And on May 26, 2020, the U.K. Department of Health announced that adults and teenagers with severe COVID-19 would be treated with Veklury (remdesivir) if they fit specific criteria. As a result, the U.S. FDA approved the antiviral drug Veklury (remdesivir) on October 22, 2020, for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. Veklury was the first treatment for COVID-19 to receive FDA approval.

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide as of January 2022. To date, Veklury and generic remdesivir have been made available to nine million patients worldwide, including 6.5 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program.

Veklury (Remdesivir) Antiviral Side Effects and Warnings

No clinical interaction studies have been performed with remdesivir, says the EMA. The overall potential for interactions is currently unknown; patients should remain under close observation during the days of remdesivir administration. Due to antagonism observed in vitro, concomitant use of remdesivir with chloroquine phosphate or hydroxychloroquine sulphate is not recommended.

On June 15, 2020, the FDA issued a drug interaction alert regarding the co-administration of Veklury (remdesivir) and chloroquine phosphate, or hydroxychloroquine sulfate may result in reduced antiviral activity. In addition, the U.S. FDA announced on August 28, 2020, broadened the scope of the existing EUA for Veklury to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 irrespective of their severity of the disease.

Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following the administration of Veklury. Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. The most common adverse reaction (≥5% all grades) was nausea. The most common lab abnormalities (≥5% all grades) were increases in ALT and AST. And drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.

Veklury (Remdesivir) Antiviral Use in Pregnant and Lactating Women

There is a limited amount of data from the use of remdesivir in pregnant women, says the EMA. Pregnancy: There is insufficient human data on the use of 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 individuals with COVID-19 should follow clinical guidelines to avoid exposing the 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.

Veklury (Remdesivir) Antiviral Dosage and Administration

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) for the treatment of 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 nonhospitalized 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 7 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.

Voluntary Licensing Agreements for Veklury (Remdesivir)

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 (Remdesivir) Antiviral 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. In the study, no deaths were observed in either arm 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 site of use. 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 (Remdesivir) Antiviral Racial Equity

A large-scale study from 41 U.S. health care systems announced on January 14, 2022, found disparate remdesivir treatment of COVID-19 in Hispanic, Black, Asian, and Other race patients relative to non-Hispanic and White patients. Mean monthly remdesivir use among inpatients who were White, Black, Asian, or Other race was 29.0%, 31.2%, 26.2%, and 30.6%, respectively; among patients of Hispanic or non-Hispanic ethnicity, remdesivir use was 30.4% and 29.3%, respectively. Black inpatients received remdesivir 9.3% more often (pt = 0.03) than did White inpatients; systematic temporal differences were also observed (pw = 0.03). Asian, other races, and Hispanic inpatients did not experience significant relative disparities.

Remdesivir Generic

India-based Zydus announced on March 24, 2021, 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.

Gilead Sciences (GILD) Veklury (Remdesivir) Revenues

December 28, 2021 - Zacks Equity Research: Can Veklury Sales Retain Momentum for Gilead in 2022? Sales of Veklury were $1.9 billion for 3Q2021. In the first nine months of 2021, Veklury sales came in at $4.2 billion.

Veklury (Remdesivir) Antiviral Treatment News

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 EU 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 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 29, 2021 - NRx Pharmaceuticals confirmed a safety update on ZYESAMI™ (aviptadil) being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns, after reviewing a total of 231 patients, and recommended continued enrollment. ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) -- alone and in combination -- in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.

September 22, 2021 - Gilead Sciences, Inc. (Nasdaq: GILD) 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 7 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. 'As we expected, variation in use was largest for remdesivir, a product shown to reduce hospital length of stay but not mortality, and smallest for dexamethasone, which has an established mortality benefit. Although not the direct focus of our research, several questions remain regarding how individual-level and health system characteristics may account for the variations in drug use that we describe.'

August 12, 2021 - This Standing Order is issued in Florida by Scott A. Rivkees, M.D., State Surgeon General. This Standing Order authorizes registered nurses licensed under chapter 464, Florida Statutes, and paramedics certified under chapter 401, Florida Statutes, who are trained in the administration of REGEN-COV to administer REGEN-COV for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death; and for post-exposure prophylaxis of COVID-19 in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID19, including hospitalization or death, in accordance with the U.S. FDA EUA for REGEN-COV (casirivimab and imdevimab), as updated, the Public Readiness and Emergency Preparedness Act and the conditions of this order.

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 29, 2021 - Gilead Sciences, Inc. announced Veklury sales were $829 million for the second quarter of 2021, exceeding Wall Street estimates of $675 million. Gilead said Veklury sales would continue to be subject to uncertainty since they are tightly linked to COVID-19 hospitalization rates. The Company also said it was no longer pursuing the development of an inhaled version of the drug for COVID-19, reported San Diego local media.

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 associated with increased use of hospital beds but not with 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. Neither remdesivir nor HCQ affected viral clearance in hospitalized patients with 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 11, 2021 - Study: Remdesivir for coronavirus disease 2019 (COVID-19): a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials. Conclusions and relevance - There is insufficient evidence to support the use of remdesivir to treat COVID-19. More high-quality RCTs are needed for stronger evidence. Until then, remdesivir should remain an experimental drug for COVID-19.

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 29, 2021 - Gilead Sciences, Inc. (Nasdaq: GILD) announced operations for the first quarter of 2021. Total first-quarter 2021 revenue of $6.4 billion increased 16% compared to the same period in 2020, primarily due to Veklury® (remdesivir) sales. Veklury sales were$1.5 billion for the first quarter of 2021.

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 (ACTT-4) has closed to enrollment because the study met pre-defined futility criteria regimen studied is likely significantly better than the other. The trial aimed to determine which of two-drug combinations—baricitinib plus remdesivir or dexamethasone plus remdesivir — was more effective at preventing adults hospitalized with COVID-19 on supplemental oxygen from progressing to requiring mechanical ventilation or death, among other outcomes. Unfortunately, an independent data and safety monitoring board found that neither treatment regimen was significantly better than the other.

April 12, 2021 - Gilead has decided to stop its Phase 3 Veklury® (remdesivir) intravenous (IV) 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 the development of 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 25, 2021 - According to a new study from the Galveston National Laboratory, published in Nature Communications, combining monoclonal antibodies and the antiviral remdesivir can make for a potent defense against the lethal Marburg virus (MARV).

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.

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 important 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 11, 2021 - Gilead Sciences, Inc. announced the Company had revised certain elements of its full-year 2020 guidance, including Vekury with $2,825M.

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 10 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.

October 15, 2020 - Study: These Remdesivir, Hydroxychloroquine, Lopinavir, and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.

October 13, 2020 - The European Union has agreed to pay Gilead more than $1.2 billion for a six-month supply of its antiviral drug remdesivir.

September 12, 2020 - Study: Multicenter interim guidance on using antivirals for children with COVID-19/SARS-CoV-2.

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. Food and Drug Administration 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. Food and Drug Administration 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 (Remdesivir) 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.

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

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. 

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.

Clinical Trials