The Food and Drug Administration announced Thursday that it had officially approved Remdesivir as the first drug to treat Covid-19. This shows the government's confidence in its safe and effective use on hospital patients.
The F.D.A. The drug has been approved for adults and pediatric patients aged 12 and over weighing at least 40 kilograms who are being hospitalized for Covid-19, the disease caused by the coronavirus that has killed more than 220,000 people in the United States States.
The F.D.A. had granted emergency remdesivir clearance in May after a study by the National Institutes of Health found it slightly reduced recovery time in hospitalized patients. President Trump received the antiviral drug after showing symptoms earlier this month. The drug does not prevent death from Covid-19.
Formal approval by the F.D.A. said the drug had cleared stricter regulatory hurdles, including a more thorough review of clinical data and manufacturing quality, since receiving emergency approval in May.
"The FDA is committed to accelerating the development and availability of Covid-19 treatments during this unprecedented public health emergency," said Dr. Stephen M. Hahn, the agent of the agency, in a statement. "Today's approval is supported by data from several clinical studies that the agency has rigorously scrutinized and that represent an important scientific milestone in the Covid-19 pandemic."
Remdesivir, originally developed to treat Ebola and hepatitis C, disrupts the reproduction of viruses by inserting itself into new viral genes. A study sponsored by the World Health Organization of more than 11,000 people in 30 countries found the drug failed to prevent deaths in patients with Covid-19.
The drug was not administered by an external panel of experts, an advisory committee, prior to its approval.
Dr. Peter Lurie, former deputy commissioner of the F.D.A. and now president of the Center for Science in the Public Interest, said that was not uncommon.
"The FDA tends, for advisory committees, to select the drugs that are the most recent and pose safety concerns and those that are closely related in terms of effectiveness," said Dr. Lurie. "This is not a blockbuster drug. This is not a massive breakthrough. It is a drug that is convincing for patients, but it is not a kind of magic bullet. "
Thursday's approval did not affect the entire population, who fell under the agency's emergency clearing in May.
This emergency permit allows clinicians to use the drug in hospitalized pediatric patients weighing between 3.5 kg and 40 kg, or in pediatric patients under 12 years of age who weigh at least 3.5 kg. Clinical studies are ongoing to evaluate the safety and efficacy of the drug in this pediatric patient population. said.
The drug was approved less than two weeks before election day as Mr Trump promised a "cure" for Covid-19. Gilead Sciences, the company that makes remdesivir, rose Thursday amid news from the F.D.A. Action.
"As part of the FDA's Coronavirus Treatment Acceleration Program, the agency will continue to help bring new medical products to patients as quickly as possible while determining whether they are effective and whether their benefits outweigh the risks," said Dr. Hahn said.
Gina Kolata and Sheila Kaplan contributed to the coverage.