A group of U.S. health advisors on Tuesday narrowly endorsed the benefits of Merck’s COVID-19 pills, which were closely watched, paving the way for the likely approval of the first drug that Americans could take at home to treat the virus.
The FDA’s 13-10 FDA voted the drug’s benefits outweigh its risks, including potential birth defects when used during pregnancy.
The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety concerns. Experts supporting the treatment emphasized that it should not be used by pregnant women and urged the FDA to recommend additional precautions before prescribing the drug, including pregnancy tests for women of childbearing age.
The vote specifically supported the drug for mild to moderate COVID-19 adults who face the greatest risk, including the elderly and people with conditions such as obesity and asthma. Most experts also stated that the drug should not be used in vaccinated patients who did not participate in the study and did not demonstrate a positive effect of the drug.
The FDA is not bound by the panel’s recommendations and is expected to make its own decision before the end of the year.
WHO warns new variant of virus poses “very high” risk
Molnupiravir may become a much-needed weapon against the virus as colder weather increases the number of cases and US officials prepare for a new version of the omicron. It is already approved for emergency use.
Merck has not specifically tested its drug against the new variant, but said it should have some efficacy based on its effectiveness against other strains of the coronavirus.
But this uncertainty frustrated many panellists who were trying to decide whether to support treatment for millions of Americans.
“Since there is no evidence that this works with new options, I really think we need to be careful about saying this is the right way,” said Dr. David Hardy of Charles Drew University’s School of Medicine and Science, who at ultimately voted for the drug, remedy, medication.
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The panel made a narrow but positive recommendation despite new data from Merck that paint a less compelling picture of the drug’s efficacy than a few weeks ago.
Merck said last week that final study results showed that molnupiravir reduced hospital admissions and deaths by 30% among adults infected with the coronavirus compared to adults taking a placebo. This effect was significantly less than the 50% reduction that was first announced based on incomplete results.
This smaller-than-expected benefit has heightened experts’ concerns about the drug’s toxicity to the human fetus.
Earlier Tuesday, FDA scientists told panelists that the company’s studies in rats showed that the drug, at very high doses, caused toxicity and birth defects. Collectively, FDA officials concluded that the data “suggests that molnupiravir may harm the fetus when administered to pregnant women.”
The FDA is weighing general restrictions against any use in pregnant women, or on rare occasions. Several group members said this option should be left open to pregnant mothers at high risk of COVID-19, who may have several other treatment options.
Dr. Janet Cragan, who endorsed the drug, said that even with tight restrictions, some pregnant women will inevitably take it.
“I don’t think it’s ethical to tell a woman with COVID-19 that she cannot take the drug if she has decided that it’s what she needs,” said a commissioner and employee of the Centers for Disease Control and Prevention. … “I think that the final decision should be for every woman and her breadwinner.”
Merck’s drug takes a new approach to combating COVID-19 by introducing tiny errors in the coronavirus’s genetic code to stop it from multiplying. This genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But on Tuesday, FDA regulators said the risk was theoretical and unlikely.
While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drug maker Pfizer has kept up with its own pending pill.
Pfizer is part of a family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C that is decades old. They work differently from Merck tablets and are not associated with the mutation problems associated with using Merck’s drug.
Pfizer said this week that its drug should not be affected by mutations in the omicron variant.
The US government has agreed to purchase 10 million Pfizer treatments, if permitted. This is more than three times the government’s agreement to purchase 3.1 million courses of molnupiravir.
Both drugs require patients to take several tablets twice a day for five days.