Virus World

The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May. The Food and Drug Administration said on Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients. The F.D.A. said the drug had been approved for adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States. The F.D.A. had granted remdesivir emergency authorization in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients. President Trump received the antiviral drug after he began showing symptom earlier this month. The drug does not prevent death from Covid-19. The formal approval by the F.D.A. indicated that the drug had cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.

“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” Dr. Stephen M. Hahn, the agency’s commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.” Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes. A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with Covid-19.  The drug did not go through an outside panel of experts, called an advisory committee, before being approved. Dr. Peter Lurie, a former associate commissioner with the F.D.A. and now president of the Center for Science in the Public Interest, said that was not unusual. “The F.D.A. tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness,” Dr. Lurie said. “This is not a blockbuster drug. This is not some massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.”

Thursday’s approval did not cover the entire population that was covered under the agency’s emergency authorization in May. That emergency authorization allows doctors to use the drug on hospitalized pediatric patients weighing between 3.5 kilograms (not quite 8 pounds) and 40 kilograms or hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kilograms. Clinical trials assessing the safety and efficacy of the drug in this pediatric patient population are ongoing, the F.D.A. said. The drug was approved less than two weeks before Election Day, as Mr. Trump has been promising a “cure” for Covid-19. Shares of Gilead Sciences, the company that makes remdesivir, rose on Thursday amid news of the F.D.A. action. “As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks,” Dr. Hahn said.

Gilead Press Release (Oct. 22, 2020):

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

Gilead has made major mid-study changes to its global remdesivir trials, quadrupling the enrollment target and switching the primary endpoint. The changes come as the world waits for results from the Chinese clinical trials of the advanced COVID-19 antiviral candidate.  Remdesivir’s position at the front of the pack of potential COVID-19 drugs and vaccines has made it a very closely watched therapeutic. In that heightened environment, any information about the drug and its development is being scrutinized for hints about whether the therapy is likely to work, making Gilead’s updates to its ClinicalTrials.gov listings notable events.

The updates detail significant changes. Across the two open-label trials, Gilead set out to enroll 1,000 patients with moderate or severe COVID-19. The primary endpoint of the trial of moderate COVID-19 patients originally looked at the proportion of patients discharged by day 14. The trial of severe patients was assessing the normalization of fever and oxygen saturation through day 14. Now, Gilead has changed all of those details. The trial of patients with severe COVID-19 has swelled in size from 400 subjects to 2,400 participants. Gilead dialed the enrollment target in the clinical trial of moderate COVID-19 patients up from 600 to 1,600. The trials have new primary endpoints, too. In each case, Gilead has changed the primary endpoint to focus on the odds of improvement on a seven-point scale that runs from death to not hospitalized. 

Gilead will enroll the additional patients in new arms it just added to the study. Both trials feature a spillover arm that will take in subjects after enrollment in the original part of the study is complete. The trial targeting patients with severe COVID-19 also features a second additional arm. Having initially only enrolled participants who had severe disease but were yet to need mechanical ventilation, Gilead has now added a cohort of mechanically ventilated patients. People enrolled in the new cohort will receive a 10-day regimen of remdesivir, the longer of the two dosing schedules being assessed in the phase 3 trials....

More details of the Clinical Trial available at:

https://clinicaltrials.gov/ct2/show/NCT04292899?term=remdesivir&draw=2&rank=3/