Veklury (Remdesivir) Antiviral Treatment Description
Veklury (remdesivir; GS-5734) is a nucleotide analog with broad-spectrum antiviral activity. Gilead's Veklury demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS coronaviruses and are structurally similar to SARS-CoV-2 causes COVID-19.
Gilead Sciences' Veklury (remdesivir) 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 for incorporation into nascent viral RNA. Incorporating RDV-TP into nascent 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. In addition, on March 7, 2021, the European Medicines Agency issued marketing approval in the EU.
On June 21, 2021, Gilead 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). All three real-world analyses observed that patients who received Veklury treatment had a significantly lower risk for mortality than matched controls in the overall patient population. In addition, a reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes throughout the pandemic and across geographies.
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, in accordance with Regulation No 1901/2006 of the European Parliament and the Council. In addition, on August 18, 2021, the EMA published the latest clinical data for Veklury (Remdesivir) EMEA/H/C/005622/R/0015.
And on September 22, 2021, Gilead announced an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo in a phase 3 study; Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In the study, no deaths were observed in either arm by Day 28.
"These latest data show remdesivir's potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether," said Robert L. Gottlieb, MD, Ph.D., Cardiologist, and Principal Investigator at Baylor University Medical Center and Baylor Scott & White Research Institute, in a press statement issued on September 22, 2021. "We are seeing very high numbers of hospitalized patients as new COVID-19 infections surge, placing increased demands on already over-burdened healthcare systems. Remdesivir, also known as Veklury, is an effective antiviral for the treatment of hospitalized patients with COVID-19 and an essential tool to help reduce disease progression."
Veklury (Remdesivir): ChemSpider ID: 58827832; ChEMBL Id: 4065616; Accession Number: DB14761 Formula: C27H35N6O8P; Molar mass: 602.585 g/mol; PubChem CID: 121304016.
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. 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.
On May 12, 2020, Mylan N.V. announced a license agreement signed with Gilead to manufacture and distribute Veklury (remdesivir) in 127 low- and middle-income countries, including India. In India, Mylan will launch the drug under the brand name DESREM.
And on May 26, 2020, the UK Department of Health announced that adults and teenagers with severe COVID-19 would be treated with Veklury (remdesivir) if they fit specific criteria.
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. 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.
On October 1, 2020, the U.S. HHS announced the Office of the Assistant Secretary for Preparedness and Response records indicate that of the 500,000 treatment courses of Veklury made available in the USA between July and September 2020, state and territorial health departments accepted 84% of their allocations (423,765 treatment courses); however, only 32% (160,981 treatment courses) of the total allocation was purchased by hospitals in their jurisdictions.
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. Thus, Veklury is the first treatment for COVID-19 to receive FDA approval. Furthermore, on December 3, 2020, the U.S. NIH stated: 'Remdesivir, an antiviral agent, is recommended for use in hospitalized patients who require supplemental oxygen. However, it is not routinely recommended for patients who require mechanical ventilation due to the lack of data showing benefit at this advanced stage of the disease.'
A study published by the NEJM on December 11, 2020, found 'The results of this randomized, double-blind, placebo-controlled trial show that combination treatment with the anti-inflammatory drug baricitinib and the antiviral drug remdesivir was safe and superior to remdesivir alone for the treatment of hospitalized patients with Covid-19 pneumonia.'
On February 12, 2021, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency concluded its review of a safety signal to assess acute kidney injury reports in patients with COVID-19 treated Veklury (remdesivir). The PRAC evaluated all available information, including data provided by the marketing authorization holder, analysis of reported adverse reactions, data from clinical trials, and published scientific literature. After considering all the data, the PRAC concluded that no evidence indicates that the reported kidney problems are associated with Veklury.
Gilead Science, Inc. (Nasdaq: GILD) is located in Foster City, CA 94404.
Veklury (Remdesivir) Antiviral Use in Pregnant and Lactating Women
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 practices according to clinical guidelines to avoid exposing the infant to COVID-19.
Veklury (Remdesivir) Antiviral Warnings and Precautions
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.
Veklury (Remdesivir) Antiviral Dosage and Administration
Dosage: 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. 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
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. Veklury is an injectable drug and should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care.
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.
The EMA updated its Veklury information sheet EMEA/H/C/005622 - R/0015 on July 8, 2021.
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.
Veklury (Remdesivir) Antiviral Treatment News
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 important 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 US 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). Presented at the World Microbe Forum, all three real-world analyses observed that patients who received Veklury treatment had a significantly lower risk for mortality than matched controls in the overall patient populations. In addition, a reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes over the course of the pandemic and across geographies. Two studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.
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.'
June 1, 2021 - According to The Pharma Letter, the Russian State Duma approved legislation that allows the production of original drugs intended for exports without the permission of a patent holder.
May 28, 2021 - Reuters reported that Russia's Supreme Court rejected a lawsuit from Gilead Sciences that challenged a Russian government to let a firm develop and market Remdesivir without Gilead's consent.
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 to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. In addition, Gilead will also donate at least 450,000 vials of Veklury® (remdesivir) to help address the immediate needs of Indian patients.
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.
April 10, 2021 - India's health ministry banned exporting the antiviral remdesivir during the COVID-19 outbreak. The review by the Indian government began on April 7, 2021.
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 US 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 UK and South Africa. According to the US 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. This approval is based on three randomized controlled trials, including the recently published, final results of the National Institute of Allergy and Infectious Diseases' double-blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19.
October 15, 2020 - Gilead issued a statement that says, 'We are aware that initial data from the World Health Organization's SOLIDARITY Trial has been made public before publication in a peer-reviewed journal. The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir).'
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.
October 8, 2020 - The U.S. NIH announced a clinical trial to test the safety, tolerability, and efficacy of a combination treatment regimen for COVID-19 consisting of the antiviral Veklury (remdesivir) plus a highly concentrated solution of antibodies that neutralize the SARS-CoV-2 coronavirus is taking place in hospitalized adults with COVID-19 in the USA, Mexico, and 16 other countries.
October 8, 2020 - The European Commission has signed a joint procurement framework contract with the pharmaceutical company Gilead to supply up to 500,000 treatment courses of Veklury, the brand name for Remdesivir, and the opportunity to increase supply beyond the 500,000 treatment courses.
October 8, 2020 - NEHM study: Remdesivir for the Treatment of Covid-19 — Final Report.
October 5, 2020 - A Living Systematic Review for an American College of Physicians Practice Points: In hospitalized adults with COVID-19, remdesivir probably improves recovery and reduces serious adverse events, and may reduce mortality and time to clinical improvement. A 5-day course of remdesivir may provide similar benefits and fewer harms than a 10-day course for adults not receiving mechanical ventilation or extracorporeal membrane oxygenation.
October 2, 2020 - US President Trump was given a Veklury (remdesivir) dose at Walter Reed National Military Medical Center as White House doctors recommended the antiviral drug to treat his COVID-19 infection.
October 1, 2020 - The U.S. Health and Human Service announcement American hospitals can now directly purchase Veklury (remdesivir) from the drug's distributor. Over the past five months, the U.S. government has overseen the allocation and distribution of Veklury due to the drug's limited supply to ensure fair and equitable distribution to COVID-19 patients.
October 1, 2020 - Gilead announced it had worked diligently to ramp up production and rapidly expand the supply of our investigational antiviral drug Veklury® (remdesivir) by making significant investments to increase internal manufacturing capacity, expand our contract manufacturing network and implement process improvements.
September 23, 2020 - Live subject testing shows a promising delivery method for COVID-19 antiviral treatment.
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.
August 10, 2020 - Gilead announced today that it had submitted a New Drug Application to the U.S. FDA for Veklury® (remdesivir). Veklury is currently available in the U.S. under an Emergency Use Authorization to treat hospitalized patients with severe COVID-19. In addition, Veklury has been approved by multiple regulatory authorities worldwide, including in the European Union and Japan.
August 7, 2020 - Pfizer has agreed to manufacture and supply Gilead Sciences' antiviral drug remdesivir at its McPherson, Kansas facility. Gilead's manufacturing network now includes more than 40 companies in North America, Europe, and Asia.
July 28, 2020 - Dry Powder Inhalation Could Be a Potent Tool in COVID-19 Antiviral Treatment.
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 10, 2020 - Gilead announced an additional analysis of remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials.
July 8, 2020 - Gilead Sciences issued the following statement from Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences: Research on this inhaled solution of remdesivir represents an important pillar of our ongoing work that aims to potentially enhance patient outcomes with remdesivir and enable more patients to access this treatment. Additional clinical trials evaluating remdesivir combined with anti-inflammatory medicines in vulnerable patient populations and outpatient settings are ongoing or planned to initiate shortly.
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. It will be available to patients in July at INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.
June 29, 2020 - The US 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 17, 2020 - Gilead has designed. It will soon begin enrollment of an open-label, single-arm Phase 2/3 clinical trial that will evaluate the safety, tolerability, pharmacokinetics, and efficacy of remdesivir in treating approximately 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents. This important trial will be conducted at more than 30 sites in the United States and Europe.
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 12, 2020 - Gilead Sciences announced that it had signed non-exclusive voluntary licensing agreements with 5 generic pharmaceutical manufacturers based in India and Pakistan to expand the supply of the experimental antiviral remdesivir. These agreements enable these companies to manufacture remdesivir for distribution in 127 countries.
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.
May 1, 2020 - ICER Presents Alternative Pricing Models for Remdesivir as a Treatment for COVID-19. ICER constructed two models, estimating cost-recovery pricing ($9.32/10-day course of treatment) and its cost-effectiveness, estimated at ~$4,500 per course.
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 coronavirus disease 2019 (COVID-19) has begun 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.
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.