Expert advisers to the Food and Drug Administration voted 13–10 in favor of the proposal to the benefits of
‘s Covid-19 antiviral molnupiravir outweighed the risks and effectively stamped the authorization for emergency use of the pill.
The FDA itself must continue to follow the recommendation, and is likely to set significant limits on the use of molnupiravir. Committee members called for restrictions on the use of birth control pills in pregnant women due to concerns about the possibility that the drug could cause birth defects.
The vote came after a rocky meeting of the FDA’s advisory committee
where some members expressed concern about the safety of the pill.
“This was clearly a very difficult decision,” said a committee member, Dr. Michael Green, a professor at the University of Pittsburgh’s School of Medicine, who voted in favor. Green said that if a Covid-19 pill were to become available with a better safety or efficacy profile, the FDA should reconsider its approval.
Another committee member, Dr. Sankar Swaminathan, a professor at the University of Utah School of Medicine who voted no to the issue, said the effect of the drug was “modest, at best,” and that the risk was not good. understood. “The risk of widespread effects on potential birth defects … has not been adequately studied,” he said.
A third member, Miriam Poirier, a researcher emeritus at the National Cancer Institute of the National Institutes of Health who voted yes, said she believed the drug should only be approved for people aged 60 and older, and that the drug should not be used during pregnancy. .
Shares in Merck rose 3.7% in pre-market trading on Wednesday.
Merck provided updated data on its pill on Friday, reporting that a phase 3 study showed an effect of 30% in a population of unvaccinated high-risk patients, down from a previous temporary analysis that had shown that the pill was 50% effective.
Some researchers have raised concerns that the mechanism used by molnupiravir to stop the virus from replicating may also cause mutations in the cells of a person taking the drug, increasing the risk of cancer or birth defects. Merck has said that tests show that this is not a problem.
Early data on Merck’s pill was met with abundance, and Merck shares climbed 17.2% in the month after the figures were announced on 1 October. Shares have since fallen, and by the end of trading on Tuesday, the rise in October had been wiped out. The stock is now down 0.3% since the first data on molnupiravir were published.
Oral antivirals such as molnupiravir may play an important role in the long-term efforts to facilitate the efficacy of Covid-19, given their ease of use in relation to available therapies. However, optimism has shifted in recent weeks away from Merck’s offerings and courage
‘s (PFE). The company reported a 89% benefit in preventing hospitalization and death, and the product does not share the same safety concerns as Merck’s drug.
Both Merck and Pfizer have said they expect their pills to be effective against the Omicron variant, although these claims are not yet supported by data.
In response to a question from the FDA during the discussion section of Tuesday’s meeting, a number of members raised concerns about offering the pill during pregnancy.
“What this comes down to for me is whether we want to reduce the risk to the mother by 30% of the injury while exposing the embryo and the fetus to a much higher risk of injury,” said Dr. James Hildreth, a temporary member of the committee. President and CEO of Meharry Medical College in Nashville, Tenn. “My answer is no.”
The committee’s chair, Dr. Lindsey Baden, summed up the committee’s views at the end of the discussion on offering birth control pills during pregnancy, saying: in a given pregnant population, versus the degree of risk, which is largely unknown. “
Members generally seemed less concerned about concerns that using the pill could create mutant strains of the virus, although Hildreth said he was concerned. “If this drug is given to millions of people in multiple environments around the world … the emergence of an escaped mutant is a real danger,” Hildreth said.
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