Vaccine Info

Veklury

Veklury (Remdesivir) Antiviral Treatment Description

Veklury (remdesivir; GS-5734) is an investigational nucleotide analog with broad-spectrum antiviral activity. Gilead Science's Remdesivir is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens.

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 COVID-19 disease. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.

As of May 1, 2020, remdesivir had been issued an Emergency Use Authorization in the USA for those hospitalized with severe disease. New data indicates it may shorten the time it takes to recover from the infection.

The FDA authorized the use of 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 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 disease will be allowed to be treated with remdesivir if they fit specific criteria. The criteria for who will get it have not been laid out by the UK government, but doctors will be expected to decide on a case-by-case basis who is most likely to benefit.

On June 15, 2020, the FDA issued a drug interaction alert regarding the co-administration of remdesivir, and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in the reduced antiviral activity of remdesivir.

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 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 the drug by the end of 2020, and anticipates being able to make “several million more” in 2021.

Gilead announced that it has 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.

Gilead Science first received a patent (US9724360B2) for the drug as a treatment for 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 at Foster City, CA 94404.

Veklury (Remdesivir) Antiviral Delivery

Treatment is given by injection into a vein. The dosage is being evaluated in various clinical studies.

In one NIH clinical trial, remdesivir is administered as one 200-milligram (mg) IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment.

On July 8, 2020, the company launched a Phase 1a clinical study to evaluate the safety, tolerability, and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. This randomized, placebo-controlled trial will enroll approximately 60 healthy individuals aged 18-45 in the United States to form the basis for a further clinical study of the inhaled drug, particularly in patients whose disease has not progressed to require hospitalization.

Veklury (Remdesivir) Antiviral Treatment News

  • 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 scope of the existing emergency use authorization for the drug Veklury.

  • 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 difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.

  • August 10, 2020 - Gilead announced today that it has 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 for the treatment of hospitalized patients with severe COVID-19. Veklury has been approved by multiple regulatory authorities around the world, 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 both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. 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 additional an 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 in outpatient settings are ongoing or planned to initiate in the near future.

  • July 6, 2020 - Mylan N.V. announced that the Drug Controller General of India has approved its remdesivir 100 mg/vial for restricted emergency use in COVID-19 patients in India. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name DESREM™ in India and will be available to patients in July at a price of 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 large supplies of the drug remdesivir for the United States from Gilead Sciences through September, allowing American hospitals to purchase the drug in amounts allocated by HHS and state health departments. HHS has secured more than 500,000 treatment courses of the drug 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 of 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 and 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 - The government of India 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 plans to launch its remdesivir in July 2020.

  • June 13, 2020 - DR.REDDY’S LABORATORIES LTD announced it can 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 compared with those in the standard of 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 will be allowed to be treated with remdesivir if they fit specific criteria. The criteria for who will get it have not been laid out by the UK government, but doctors will be expected to decide on a case-by-case basis who is 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 to further 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 for the treatment of 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 time to recovery 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 poor 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. The detailed results of this analysis were published today in The New England Journal of Medicine.

  • On 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 forms of the disease 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.”

  • 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)
    • The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to 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), with respect to 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
Updated
09/10/2020 - 06:37