Much-touted antiviral drug gains full approval following EUA

WASHINGTON — The FDA granted full approval to the antiviral drug remdesivir (Veklury) to treat patients 12 years and older who are hospitalized with Covid-19, making it the first FDA-approved treatment for Covid-19.

This approval, the agency noted, applies to pediatric patients who weigh at least 40 kg, or roughly 88 pounds.

Remdesivir has been a topic of great interest over the course of the Covid-19 pandemic since evidence of efficacy led to an Emergency Use Authorization (EUA) for the drug back in May — it was among the treatments given to President Donald Trump after he was hospitalized with the coronavirus at the start of October, and the American College of Physicians backed use of the drug in a recent Rapid Living Practice Points this month. Most recently, a study by the World Health Organization (WHO) cast doubt on remdesivir and a host of other experimental Covid-19 therapies after the agents failed to significantly reduce Covid mortality or hasten recovery. However, the FDA decided that the drug’s benefits outweigh the risks, granting remdesivir Fast Track and Priority Review designations.

“This approval does not include the entire population that had been authorized to use [remdesivir] under an Emergency Use Authorization (EUA) originally issued on May 1, 2020,” the FDA noted in a press release. “In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for [remdesivir] to authorize the drug’s use for treatment of suspected or laboratory confirmed Covid-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of [remdesivir] in this pediatric patient population are ongoing.”

This approval was based on results from three randomized, controlled clinical trials including patients hospitalized with mild-to-severe Covid-19, the FDA explained: the randomized, double-blind, placebo-controlled ACTT-1 trial, and two additional trials, one assessing the drug in patients with moderate disease and one assessing patients with severe disease. Among the results:

  • In the ACTT-1 trial, conducted by the National Institute of Allergy and Infectious Diseases, recruited 1,062 hospitalized subjects with mild, moderate, and severe Covid-19 who received either remdesivir (n=541) or placebo (n=521). The median time to recovery was 10 days in the remdesivir group and 15 days in the placebo group, and the odds of clinical improvement at Day 15 were also significantly higher in the remdesivir group.
  • The second trial compared 5-day (n=191) and 10-day (n=193) with remdesivir against standard care (n=200) in patients hospitalized with moderate Covid-19. “Overall, the odds of a subject’s Covid-19 symptoms improving were statistically significantly higher in the five-day [remdesivir] group at Day 11 when compared to those receiving only standard of care,” the agency explained. “The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different.”
  • The third trial compared 5-day (n=200) and 10-day (n=197) courses of remdesivir among hospitalized Covid-19 patients. “Overall, the odds of a subject’s Covid-19 symptoms improving were similar for those in the five-day [remdesivir] group as those in the 10-day [remdesivir] group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups,” the FDA wrote.

Potential side effects of remdesivir include “increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering,” the FDA warned. “Similar safety information about using [remdesivir] to treat Covid-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and patients/caregivers.”

Remdesivir is manufactured by Gilead Sciences Inc.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,926,192,927,151,725,928,925,934