The Food and Drug Administration advisory committee said Tuesday the benefits of Merck & Co.’s experimental antiviral COVID-19 pill outweigh its risks in a 13-10 vote, with several advisers saying they had concerns about the use of the drug in pregnant women.
Shares of Merck, rose 2% in after-hours trading on Tuesday after ending the regular trading day up a fraction. The company is developing the pill, which is called Molnupiravir, with privately held Ridgeback Biotherapeutics.
The FDA is now expected to deliver its final decision, likely before the end of the year. The regulator often takes into account the recommendation of its advisory committees but is not required to do so.
If Molnupiravir is authorized by the FDA in the coming weeks, as expected, the treatment will be the first oral COVID-19 pill that patients can take at home.
Members of the Antimicrobial Drugs Advisory Committee also suggested a safety-monitoring program, expressed concerns about prescribing the drug to those who are immunocompromised and shared their concerns about the overall efficacy of the pill.
“With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed. That is why we are moving with speed and rigor to pursue authorizations and to accelerate broad global access to this investigational medicine,” Dean Li, executive vice president and president of Merck Research Laboratories, said in a statement. “We are grateful to the members of the advisory committee who reviewed our application, as well as to the patients and investigators who participated in our clinical trials, and we will continue to work with the FDA as the agency completes its review.”
Some Wall Street analysts had predicted that the advisers would vote in support of authorization, but with a cautious approach.
“Despite these reservations, Molnupiravir is also likely to be approved, and demand is likely to exceed their 20 [million] course supply in 2022,” SVB Leerink analysts wrote on Friday.
Merck is seeking authorization for Molnupiravir in adults who have tested positive for the virus, are experiencing mild or moderate symptoms, and are at high risk for severe disease. Patients are expected to start treatment within five days of symptoms.
The Phase 2/3, randomized, placebo-controlled, double-blind study only enrolled unvaccinated people; however, it’s unclear whether the pill could be used to treat vaccinated individuals with breakthrough infections if it is authorized.
Molnupiravir has already been authorized for use in the U.K.
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