FDA unlikely to rule on Merck’s COVID pill until December

The FDA said Thursday it will ask its external experts to meet at the end of November to scrutinize Merck’s COVID-19 pills.

The November 30 meeting means that US regulators will almost certainly not make a decision on the drug until December, signaling that the agency will conduct a detailed review of the safety and efficacy of experimental treatments. Commissioners are likely to vote to approve Merck’s drug, although the FDA is not required to follow their advice.

This is the first time the FDA has brought together its expert advisors before deciding on a treatment for the coronavirus. Advisory committee meetings have become a standard part of the vaccine validation process.

The agency has decided to call a meeting to help guide decisions, its main drug regulator said in a statement.

“We believe that in this case, public discussion of this data with the agency’s advisory committee will help ensure a clear understanding of the scientific evidence and information that the FDA is evaluating,” said Dr. Patricia Cavazzoni, director of the FDA’s pharmaceutical center.

The FDA said the appointment was made as soon as possible following Merck’s request. The November date will allow the agency’s scientists to review the application before the meeting, the agency said.

On Monday, Merck and partner Ridgeback Biotheotherapy filed an application with the FDA to authorize emergency use for adults with mild to moderate COVID-19 who are at risk of serious illness or hospitalization. This is roughly the same indication as available infusion drugs.

Since last year, three intravenous antibody-based drugs have been authorized to reduce hospitalizations and deaths from COVID-19, but they are expensive, difficult to manufacture, and require specialized equipment and healthcare professionals to deliver. If approved, Merck’s drug, molnupiravir, will be the first drug that patients can take at home to relieve symptoms and speed up recovery.

Earlier this month, the company announced preliminary results that halved the number of hospitalizations and deaths among patients with early symptoms of COVID-19. The results have not yet been peer reviewed, which is standard practice for validating such studies.

The company also did not disclose details of the side effects of molnupiravir, except that it noted that the frequency of these problems was similar between people who took the drug and those who took pacifiers.

If permitted, Merck is likely to be the first, but not the only, pill to treat COVID-19. Pfizer, Roche and Appili Therapeutics are investigating similar drugs and are expected to report results in the coming weeks and months.

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