FDA authorizes Merck antiviral COVID pill for certain high-risk adults
The Food and Drug Administration on Thursday authorized an antiviral pill developed by Merck and Ridgeback Biotherapeutics to treat some adults at high risk of becoming severely ill from COVID-19, despite concerns over its effectiveness and safety.
Why it matters: Effective at-home antiviral drugs designed to prevent or treat COVID-19 could be key pandemic-fighting tools, especially as new variants emerge.
- The emergency use authorization comes as the U.S. sees a surge in new COVID-19 cases and hospitalizations largely driven by the Omicron variant.
Details: The FDA authorized the drug, known as molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe illness and "for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
- The FDA on Wednesday authorized Pfizer's antiviral COVID pill, known as Paxlovid, for high-risk individuals. 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.
Driving the news: Merck said last month 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.
- "Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth," the FDA said.
Between the lines: Enthusiasm for the drug has waned a bit since Merck released its updated data, which showed molnupiravir was less effective than initially reported.
- One expert on an FDA advisory panel that endorsed the drug in a 13-10 vote pointed out that “the efficacy of this product is not overwhelmingly good.”
What they're saying: "Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
- “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” she added.
The big picture: The Biden administration has already agreed to purchase enough courses of the drug for at least 3 million people.
- This week's emergency use authorizations for the Merck and Pfizer pills come as researchers work to gather more information on the fast-spreading Omicron variant.
- A Merck executive told the FDA advisory committee in late November that the company was "feverishly working" to gather samples from people with Omicron to help determine whether molnupiravir was effective against the new variant, according to the New York Times.
- Dr. Nicholas Kartsonis said the company expects "based on what we know about the Omicron variant that molnupiravir would be effective," per the Times.
- Kartsonis' comments echoed similar statements by other experts who say antiviral drugs like Merck's appear to be unaffected by the Omicron variant due to the way the treatment works.