FDA: Merck COVID pill effective, although lower than previous indications. Experts will review safety

FDA: Merck COVID pill effective, experts will review safety | AP News Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. AP NEWS

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The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.

The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals.

Given those risks the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases. ...

The pharmaceutical company Merck said on Friday that in a final analysis of a clinical trial, its antiviral pill reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent, down from an earlier estimate of 50 percent.

The lower efficacy is a disappointment for the drug, known as molnupiravir, which health officials around the world are counting on as a critical tool to save lives and reduce the burden on hospitals. It increases the importance of a similar, apparently more effective, offering from Pfizer that is also under review by the Food and Drug Administration.