Merck’s Covid-19 Pill Set for Review by FDA Advisory Panel

(Bloomberg) -- The U.S. Food and Drug Administration is sending Merck & Co.’s Covid-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorization.

The FDA announced the hearing for Nov. 30, saying it would weigh data on the use of the drug, molnupiravir, to treat mild-to-moderate cases in high-risk adults, confirming an earlier report by Bloomberg News. It’s the first potential therapeutic treatment for Covid-19 that the agency referred to an advisory panel, the FDA said. 

“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The agency opted not to skip the advisory committee step, which it occasionally does when it’s racing to get a drug to market quickly -- and as it has done with earlier treatments for Covid-19. Safety concerns have been raised by some experts, and the committee will weigh in before the FDA makes a decision. The FDA plans to present its perspective on the company’s data to the panel. 

Merck didn’t respond to a request for comment.

Merck and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir earlier this week, a step toward clearance for a pill meant to treat Covid-19 in high-risk adults. The committee meeting was scheduled “as soon as possible” after the emergency use request, the FDA said in a statement.

Kenilworth, New Jersey-based Merck agreed in June to a $1.2 billion supply deal to provide the U.S. government 1.7 million courses of treatment once the drug gains FDA authorization or approval.

Molnupiravir works by introducing errors into viral genetic material that eventually make the pathogen defunct. Some experts have questioned whether and how the drug may also impact growing cells in the human body, potentially raising the risk of birth defects, for example. 

Nicholas Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck Research Labs, said in an interview last week that he’s been “very impressed” by the drug’s safety profile and that it looks “really clean.” In trials, more people stopped taking the placebo due to serious adverse events than the drug itself, he said. 

Kartsonis added that Merck has shared publicly a limited amount of data regarding the drug’s safety, but that the company intends to report more soon. “We send these things to health authorities, and we’ll work with them as they look at it carefully,” he said.

An advisory committee is a step in the process toward authorization, and is a public forum. Any recommendation from the panel would then be subject to review by the FDA itself. 

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