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FDA review finds Merck’s COVID-19 pill effective, but flags safety concerns

Merck's experimental COVID-19 pills
U.S. health officials say Merck’s experimental COVID-19 pill is effective, but they raised questions about its safety during pregnancy.
(Merck & Co. via Associated Press)

Federal health regulators say an experimental COVID-19 pill developed by Merck is effective against the coronavirus, but they will seek input from independent advisors on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill last week ahead of a public meeting Tuesday, when a panel of experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the panel’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 conducted in animals.

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Given those risks, the FDA will ask its advisors 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.

Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.

“While the clinical safety data base was small, there were no major safety concerns identified,” FDA reviewers concluded.

Drugmaker Merck says its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus.

Additionally, the FDA scientists flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, they cautioned, those changes could lead to dangerous new variants.

FDA will ask the advisory panel to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks.

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 Britain.

The meeting will mark the first time regulators publicly review a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans.

The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate cases of COVID-19.

Merck’s drug uses a novel approach to fight the virus: 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 the development of more virulent strains of the virus.

Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex.

A long-standing tradition of keeping pregnant women out of clinical trials is having serious consequences with regard to COVID-19.

For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied.

FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems.

However, on Friday, Merck announced updated results from the same study that showed a smaller benefit from the drug. The FDA said it is still reviewing the updated data and would present a new assessment of the drug’s effectiveness on Tuesday.

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 developing COVID-19 symptoms ended up in the hospital and one died. Among patients who got the placebo, 10% were hospitalized and nine died.

Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask the advisory panel to recommend which patients may stand to benefit most from the drug, based on vaccination status and underlying health problems.

Pfizer says that in studies its COVID-19 pill cut rates of hospitalization and death by nearly 90% in high-risk adults.

While Merck’s drug is likely to be the first pill for COVID-19 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%.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug.


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