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FDA Experts Will Review Merck’s COVID19 Pill After Panel Says It’s Effective

FDA Experts Will Review Merck’s COVID19 Pill After Panel Says It’s Effective

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 the risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration (FDA) 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.

All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.

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. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children. Other side effects were mild and rare, with about 2% of patients experiencing diarrhea.

The Associated Press reports that Merck’s drug, called Molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus, the AP’s report says.

Among more than 1,400 adults in a company study, Molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems.

While Merck’s drug is likely to be the first pill for coronavirus in the U.S., more are expected to follow. Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalization and death by nearly 90%.

 

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