Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek advice from outside experts on the risks of birth defects and other potential problems during pregnancy.
The Food and Drug Administration released its review of the pill ahead of a public meeting next week where academic and other experts will comment on its safety and effectiveness. The agency is under no obligation to follow the advice of the group.
FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects identified in animal studies of the pill.
Given these risks, the FDA will ask its advisers next Tuesday whether the drug should never be administered during pregnancy or if it could be made available in certain cases.
In this scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option of prescribing it in certain cases where its benefits could outweigh its risks to patients.
Given safety concerns, the FDA said Merck agreed the drug would not be used in children.
Other side effects were mild and rare, with around 2% of patients suffering from diarrhea.
Regulators also noted that Merck collects significantly less safety data on its drug overall than that collected for other COVID-19 therapies.
“Although the clinical safety database is small, no major safety issues have been identified,” the FDA reviewers concluded.
Additionally, the FDA has reported concerns that Merck’s drug may cause small changes in the spike protein characteristic of the coronavirus, which it uses to enter human cells. Theoretically, the FDA warned, these changes could lead to dangerous new variants.
The FDA will ask its independent advisers to discuss all of these issues and then vote on whether the drug’s overall benefits outweigh its risks.
All COVID-19 drugs currently approved by the FDA require an injection or intravenous and can only be administered by healthcare professionals. If approved, Merck’s drug would be the first American patients could take at home to relieve symptoms and speed recovery. It is already licensed for emergency use in the UK
The meeting marks the first time that regulators have publicly reviewed a new drug for COVID-19, reflecting intense interest and scrutiny of a pill that could soon be used by millions of Americans.
The drug, molnupiravir, has been shown to significantly reduce the rate of hospitalizations and death in people with mild to moderate coronavirus infections.
Merck’s drug uses a new approach to fight COVID-19: it inserts tiny mutations into the genetic code of the coronavirus to prevent the virus from reproducing.
But this genetic effect has raised fears that in rare cases the drug could cause birth defects or even stimulate more virulent strains of the virus.
Pregnant women were excluded from the Merck study, and both women and men in the study were instructed to use contraception or to abstain from sex.
For its part, Merck says the results of two company studies in rodents show that the drug does not cause mutations or DNA damage at the doses studied.
FDA examiners also confirmed previously reported interim results from Merck that the pill reduced the rate of hospitalization and death by about half in patients with early symptoms of COVID-19 who faced increased risk. due to health issues.
However, on Friday morning, Merck announced updated results from the same study which showed less benefit from the drug. The FDA said it is still reviewing the updated data and will present a new assessment of the drug’s effectiveness next 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.
Almost 7% of patients who received the drug from Merck within five days of COVID-19 symptoms ended up in hospital and one died. This compared to 10% of hospital patients taking the placebo and nine deaths.
Merck has not studied its drug in people vaccinated against COVID-19. But the FDA will ask advisers to recommend which patients could benefit the most from the drug, based on vaccine status and underlying health issues.
While Merck’s drug is likely the first coronavirus pill in the United States, more are expected to follow.
Rival drugmaker Pfizer submitted its own antiviral for FDA review after initial study results showed it reduced 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 have revolutionized the treatment of HIV and hepatitis C. They work differently from the Merck pill. and have not been linked to the type of mutation issues that have arisen. with the drug from Merck.
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