FDA panel backs Merck's antiviral COVID pill
An FDA advisory panel on Tuesday voted 13-10 to endorse an antiviral pill developed by Merck and Ridgeback Biotherapeutics to treat adults at high risk of becoming severely ill from COVID-19, despite concerns over its effectiveness and safety.
Why it matters: Oral antiviral drugs designed to prevent or treat COVID-19 could be key pandemic-fighting tools, if proven effective, especially as new variants emerge. If authorized, the Merck drug, known as molnupiravir, would be the first treatment of its kind to be made available in the U.S.
- Most of the panelists said they believed there should be limits on the use of the drug and that the FDA should not approve its use for pregnant women or children. Several expressed concern over the "safety profile" of the drug and said it should be used strictly with high-risk individuals.
Driving the news: Merck said last week that molnupiravir reduced the risk of hospitalization or death for patients with mild or moderate COVID-19 by about 30%, based on a study of more than 1,400 adults.
- The treatment is started within five days of the onset of symptoms and can be administered at home.
Between the lines: Enthusiasm for molnupiravir has waned a bit since Merck released its updated data last week showing the drug was less effective than initially reported.
The big picture: The advisory panel's vote comes as countries rush to respond to the emergence of the Omicron variant.
- More research is needed, but Michel Nussenzweig, an immunologist at Rockefeller University, told the Wall Street Journal that antiviral drugs like Merck's appear to be unaffected by the new variant due to the way the treatment works.
What's next: The FDA must still decide whether to follow the panel's recommendation, though it typically does.
- If authorized, the pill's supply is expected to be limited at first, the New York Times reports. The Biden administration has already agreed to purchase enough courses of the drug for about 3.1 million people.
What to watch: Pfizer has also asked the FDA for emergency authorization of a similar antiviral pill it developed called Paxlovid.
- The Pfizer pill regimen was shown in clinical trials to reduce the risk of hospitalization and death by 89% in people at high risk of severe COVID-19, according to the company.