The Food and Drug Administration (FDA) said Thursday it will ask its outside experts to meet in late November to examine Merck’s pill for treating COVID-19.
The November 30 meeting means that US regulators will almost certainly not issue a decision on the drug until December, indicating that the agency will conduct a detailed review of the safety and efficacy of the experimental treatment. Panelists are likely to vote on whether to approve the Merck drug, although the FDA is not required to follow their advice.
It is the first time that the FDA has convened its expert advisers before ruling on a treatment for the coronavirus. Advisory committee meetings have become a standard part of your vaccine review process.
The agency decided to call the meeting to help inform its decision-making, its top drug regulator said in a statement.
“We believe that, in this case, a public discussion of these data with the agency’s advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating,” said Dr. Patrizia Cavazzoni, director of the FDA Drug Center.
The FDA said the meeting was scheduled as soon as possible following Merck’s request. The November date will allow agency scientists to review the application before the meeting, the agency said.
Merck and its partner Ridgeback Biotherapeutic submitted their application to the FDA on Monday, asking the agency to grant emergency use for adults with mild to moderate COVID-19 who are at risk of serious illness or hospitalization. That is roughly the same indication as the available infusion medications.
Since last year, three intravenous antibody drugs have been licensed to reduce hospitalization and death from COVID-19, but they are expensive, difficult to produce, and require specialized teams and healthcare professionals to deliver them. If licensed, Merck’s drug, molnupiravir, would be the first that patients could take at home to relieve symptoms and speed recovery.
The company announced preliminary results earlier this month showing its drugs cut hospitalizations and deaths in half among patients with early symptoms of COVID-19. The results have not yet been peer-reviewed, the standard practice for examining such research.
The company has also not released details about the side effects of molnupiravir, except to say that the rates of those problems were similar between people who received the drug and those who received fake pills.
If licensed, Merck’s drug is likely to be the first, but not the only, pill to treat COVID-19. Pfizer, Roche and Appili Therapeutics are studying similar drugs and are expected to report the results in the coming weeks and months.