FDA authorizes experimental drug remdesivir for emergency use in COVID-19 patients
The Food and Drug Administration just authorized the emergency use of remdesivir, an experimental anti-viral drug, to treat COVID-19.
Emergency authorization does not mean that the drug is FDA-approved, a standard that only comes after a detailed review showing a drug can safely and effectively treat a particular disease. The agency can issue an emergency use authorization (EUA) for unapproved medical products that may help treat a life-threatening disease when no approved alternatives are available — that’s what it did here.
The authorization does not mean the drug was proven to work by the FDA’s usual benchmarks, but that it “may be effective in treatment of patients during the COVID-19 pandemic,” according to the agency’s fact sheet.
Research showing that remdesivir blocks the activity of the novel coronavirus in cells made it a leading candidate to treat the disease. The drug was developed by the pharmaceutical company Gilead to treat Ebola. Prior to this authorization, doctors could treat COVID-19 patients with remdesivir by enrolling them in clinical trials or making individual requests to the drug company under the FDA’s compassionate use policy.
Data from clinical trials of the drug has been mixed. The National Institute of Allergy and Infectious Diseases (NIAID) said this week that patients in their study who were treated with remdesivir recovered from COVID-19 four days faster than patients who were given a placebo. Eight percent of the group given the drug died, compared with 11 percent of the placebo group. The NIAID said it will release more detailed data on the study, which included over 1,000 patients, later on — leaving the findings difficult to critically analyze at this point.
Anthony Fauci, director of the NIAID, called the results “good news.” “What it has proven is a drug can block this virus,” he said in the White House this week. Former FDA commissioner Scott Gottlieb had a more reserved take on the results. “Evolutionary, not revolutionary,” he tweeted.
Good, succinct take by @CarlosdelRio7. Evolutionary, not revolutionary. Remdesivir appears active, may help some patients. A beginning. We’ll need better drugs and ultimately a vaccine. But this could help if used appropriately, especially if we also have antibody drugs by Fall. https://t.co/gUt7M6AGpt
— Scott Gottlieb, MD (@ScottGottliebMD) April 29, 2020
However, a Chinese study also published the same day found that patients given the drug did not improve more quickly than patients who were treated with a placebo. “Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” the lead investigator of the study, Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing, told The New York Times.
Testing drugs is hard under normal circumstances and even more challenging during an active pandemic. The novel coronavirus is killing thousands of people every day, and people all around the world are desperate for answers — putting tremendous pressure on any new data and inflating any positive signal. No drug has proven to be a safe and effective treatment for COVID-19, and research into remdesivir and other treatment candidates continues.
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The Food and Drug Administration just authorized the emergency use of remdesivir, an experimental anti-viral drug, to treat COVID-19. Emergency authorization does not mean that the drug is FDA-approved, a standard that only comes after a detailed review showing a drug can safely and effectively treat a particular disease. The…
