Veklury (Remdesivir) Antiviral Treatment Description
Veklury (remdesivir; GS-5734) is a nucleotide analog with broad-spectrum antiviral activity. Gilead's Veklury has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses, and are structurally similar to SARS-CoV-2 which causes COVID-19.
Gilead Sciences' Veklury acts to inhibit the SARS-CoV-2 RNA-dependent RNA polymerase, which is essential for viral replication, says the company.
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. The incorporation of RDV-TP into nascent viral RNA results in delayed chain termination (position i+3), which disrupts SARS-CoV-2 viral RNA replication.
Veklury 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.
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 company stated, 'Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.'
Novel drugs approved in 2020 that FDA identified as first-in-class include Veklury (Remdesivir): ChemSpider ID: 58827832; ChEMBL Id: 4065616; Accession Number: DB14761
Veklury (Remdesivir) Antiviral Treatment History
As of May 1, 2020, Veklury (remdesivir) was issued an Emergency Use Authorization in the USA for hospitalized with severe disease. Recent data indicates it may shorten the time it takes to recover from the infection.
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. The UK government has not laid out the criteria for who will get it, but doctors will be expected to decide on a case-by-case basis, most likely to benefit.
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.
Gilead Sciences Merdad Parsey, M.D, Ph.D., Chief Medical Officer, stated on June 17, 2020, 'Gilead has designed an open-label, single-arm Phase 2/3 clinical trial that will evaluate the safety, tolerability, pharmacokinetics, and efficacy of Veklury (remdesivir) in treating approximately 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents, which was last updated on August 4, 2020.
On August 7, 2020, Gilead said it plans to produce more than 2 million treatment courses of Veklury by the end of 2020 and anticipates making “several million more” in 2021.
Gilead announced that it had submitted a New Drug Application to the U.S. FDA for Veklury® (remdesivir) on August 10, 2020.
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 actually purchased by hospitals in their jurisdictions.
On October 8, 2020, Gilead issued a statement: 'Overall, Treatment with Veklury Resulted in 5-Days Faster Recovery and Reduced Disease Progression Compared with Placebo. Veklury Reduced Mortality by 70% at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc Analysis.
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 is the first treatment for COVID-19 to receive FDA approval.
On November 20, 2020, the WHO's Therapeutics and COVID-19 document stated, 'there is currently no evidence that remdesivir improves survival and other outcomes in these patients.'
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.'
“Gilead continues to play a central role in the pandemic, with Veklury now treating one in two hospitalized patients in the United States,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences, in a press statement issued on February 4, 2021.
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 with Veklury (remdesivir). The PRAC assessed 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 there is no evidence indicating that the reported kidney problems are associated with Veklury.
Gilead Science first received a patent (US9724360B2) for the drug to treat Ebola in 2017. In fall 2015, Gilead applied for two patents for remdesivir, one for combating coronaviruses and another for filoviruses, the family of pathogens that includes Ebola. Both were approved in spring 2019.
Gilead Science, Inc. is located in Foster City, CA 94404.
Veklury (Remdesivir) Antiviral Delivery
The Veklury 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.
Treatment is given by injection into a vein. Empiric treatment of hospitalized patients with suspected COVID-19 can be considered pending laboratory confirmation of SARS-CoV-2 infection. VEKLURY can be used at any time after the onset of symptoms in hospitalized patients.
The recommended dosage for pediatric patients weighing 3.5 kg to less than 40 kg is a single loading dose of VEKLURY 5 mg/kg on Day 1, followed by VEKLURY 2.5 mg/kg once daily from Day 2. The recommended dosage for pediatric patients less than 12 years of age and weighing 40 kg and higher is a single loading dose of 200 mg on Day 1 followed by once-daily maintenance doses of 100 mg from Day.
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 Treatment News
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, which will be 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 operations results for the 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. Complexities related to the quality and sourcing of the remdesivir active pharmaceutical ingredient (API) and formulation of remdesivir drug products may make these drugs particularly challenging to the compound. Remdesivir API is complex, and neither a United States Pharmacopeia (USP) monograph nor other public quality standards for the API used in FDA-approved remdesivir are available. Remdesivir API has six stereocenters and has multiple polymorphic forms.2,3 Using API forms that differ from the API in the FDA-approved drug may affect the compounded drug’s quality, including the API's solubility in the compounded 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 being administered anti-viral drug remdesivir.
December 30, 2020 - Researchers at the University of Cincinnati say an antiviral drug being used to treat Covid-19 is being used too indiscriminately on patients hospitalized with the virus, and physicians who opt to use it 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 results from the ACCT-1 trial 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. Male Ebola survivors assigned to a 5-day course of Veklury indicated that the drug was at least modestly effective. The participants' semen was increasingly found negative for Ebola RNA.
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 the time to 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 - NIH study announced a phase 2 study would test risankizumab, a monoclonal antibody developed by Boehringer Ingelheim (Ridgefield, Connecticut) and AbbVie (North Chicago, Illinois), in conjunction with the antiviral drug remdesivir, compared to placebo plus remdesivir. The ACTIV-5/BET trial will test the investigational monoclonal antibody lenzilumab, developed by Humanigen, with remdesivir, compared to placebo and remdesivir. Remdesivir has demonstrated clinical benefit for patients with severe COVID-19 requiring supplemental oxygen and is considered standard of care for hospitalized COVID-19 patients.
October 13, 2020 - The European Union has agreed to pay more than $1.2 billion to Gilead 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. The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG, which come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19.
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 to 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 dose of Veklury (remdesivir) 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. As a result of making early investments to increase Veklury manufacturing efforts, Gilead meets real-time demand for Veklury in the United States. It anticipates meeting global demand for Veklury in October, even in potential future surges of COVID-19.
September 23, 2020 - Live subject testing shows a promising delivery method for COVID-19 antiviral treatment.
September 12, 2020 - Study: Multicenter interim guidance on the use of 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 the drug Veklury. Gilead Sciences's expanded the Emergency Use Authorization (EUA), enabling the use of 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. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia and results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.
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 than 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. 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.
August 6, 2020 - Since January, Gilead has taken multiple steps to ramp up production and rapidly build the supply of our investigational COVID-19 treatment Veklury® (remdesivir), preparing for potential global demand at risk in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead has expanded its global network of internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity worldwide. Our Veklury 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 in combination 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 are also suffering 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 22, 2020 - Daniel O’Day, Chairman & CEO, Gilead Sciences, announced: After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 disease in August 2020.
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 14, 2020 - India's government released guidelines for doctors to use investigational antiviral medication remdesivir in treating India’s Covid-19 patients. Most generic pharma companies hoping to produce and supply the drug in India are still awaiting approval from the Central Drugs Standard Control Organisation. Only Jubilant Life Sciences confirmed it received “conditional approval” for its generic version “subject to certain criterion being met.” It planned to launch its remdesivir in July 2020.
June 13, 2020 - DR.REDDY’S LABORATORIES LTD announced it could register and sell Remdesivir in 127 countries.
June 3, 2020 – Early results from a late-stage clinical study showed that remdesivir benefited hospitalized patients diagnosed with severe COVID-19 disease who required supplemental oxygen. The analysis found that remdesivir shortened the time to recovery, which was defined as being medically stable enough to be discharged from the hospital.
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 28, 2020 - Roche announced the initiation of a global phase III, randomized, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra, plus the investigational antiviral remdesivir in hospitalized patients with severe COVID-19 pneumonia.
May 26, 2020 - The UK Department of Health announced that adults and teenagers with severe COVID-19 disease would be allowed to be treated with remdesivir if they fit specific criteria. The UK government has not laid out the criteria for who will get it, but doctors will be expected to decide on a case-by-case basis, most likely to benefit.
May 22, 2020 - Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.
May 15, 2020 - Gilead Sciences Inc’s two clinical studies of its potential coronavirus treatment remdesivir will wind down by the end of May, closing off a path of patient access to the antiviral medication, according to U.S. researchers involved in the studies.
May 13, 2020 - Inside Gilead’s COVID-19 Response Efforts.
May 12, 2020 - Gilead Sciences announced on it has signed non-exclusive voluntary licensing agreements with 5 generic pharmaceutical manufacturers based in India and Pakistan further to expand the supply of the experimental antiviral remdesivir. These agreements enable these companies to manufacture remdesivir for distribution in 127 countries.
May 9, 2020 - The U.S. Department of HHS announced the allocation plan for the drug remdesivir. The donated doses by Gilead Sciences, Inc., which received a EUA from the U.S. FDA, will be used to treat hospitalized COVID-19 disease patients in areas of the country hardest hit by the pandemic.
May 8, 2020 - NIH clinical trial testing antiviral remdesivir plus anti-inflammatory drug baricitinib for COVID-19 begins.
May 3, 2020 - Gilead Sciences announced it would donate its entire supply of the Remdesivir IV-delivered drug to the U.S. government.
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, one estimating cost-recovery pricing ($9.32/10-day course of treatment) and one 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 those who received 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 23, 2020 – Gilead Sciences issued the following statement from Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences: “Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website. This information has since been removed, as the study investigators did not provide permission for the publication of the results."
April 15, 2020 - Gilead’s remdesivir study in China for mild-moderate COVID-19 patients has just been suspended due to insufficient enrollment. The news comes as the pandemic continues to wane in China and follows the recently announced termination of the study for severe COVID-19 patients for similar reasons. According to reports, the mild-moderate study had planned to enroll 308 patients from Wuhan- but it remains unclear exactly how many enrolled to date.
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. The majority of 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.
April 9, 2020 - Gilead Sciences increased the number of participants in 2 ongoing clinical trials for remdesivir, its experimental treatment for COVID-19 disease. According to ClinicalTrials.gov, Gilead increased the number of study participants in a Phase 3 trial for people with moderate disease forms to 1,600 from 600. It did the same for a similar trial evaluating remdesivir in patients with severe COVID-19, to 2,400 participants from 400. The first results from these clinical trials are expected in May 2020.
April 4, 2020 - An Update on COVID-19 from our Chairman & CEO, Daniel O’Day.
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 Phase 2/3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing.
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. More than half of patients in both treatment groups were discharged from the hospital by Day 14.
The Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the NIAID, the preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery (11 days) than those who received placebo. “We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, M.D. “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.” Last Update Posted: November 17, 2020.
- ClinicalTrials.gov Identifier: NCT04431453: Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to 18 Years of Age With Coronavirus Disease 2019 (COVID-19) (CARAVAN).
- The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
- Clinical Trial NCT04292899: Phase 3 Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
- This study's primary objective is to evaluate the efficacy of 2 remdesivir (RDV) regimens concerning the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).
- Clinical Trial NCT04292730: Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment.
- The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC) concerning the time to discharge in participants with moderate coronavirus disease (COVID-19).
- Clinical Trial NCT04280705: Adaptive COVID-19 Treatment Trial (ACTT)
- Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo.
- Clinical Trial NCT04257656: Severe 2019-nCoV Remdesivir RCT
- Clinical Trial NCT04252664: Mild/Moderate 2019-nCoV Remdesivir RCT
- INSERM French study: 2020-000936-23: DisCoVeR