FDA team supports Merck’s first COVID pill
On Tuesday, a team of American health advisors grudgingly supported the benefits of the COVID-19 pill that Merck was watching closely, laying the foundation for the possible approval of the first drug for Americans to treat the virus at home.
A team from the Food and Drug Administration voted 13 to 10 to pass the drug’s benefits outweigh its risks, including potential birth defects during pregnancy.
The group’s recommendations were made after hours of debate on the drug’s moderate benefits and potential safety issues. Experts supporting this treatment emphasize that anyone who is pregnant should not use it, and called on the FDA to recommend additional precautions before prescribing the drug, including pregnancy tests for women of childbearing age.
The vote specifically supports the use of the drug in adults with mild to moderate COVID-19 who are most at risk, including the elderly and those with diseases 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 show any benefit from the drug.
The FDA is not bound by the expert panel’s recommendations and is expected to make its own decision before the end of the year.
As cold weather increases the number of cases and US officials prepare for the arrival of a new variant of omicron, the drug monelavir can provide a much-needed antiviral weapon. It has been authorized for emergency use.
Merck has not specifically tested its drug against the new variant, but said it should be effective based on its effectiveness against other coronavirus strains.
But this uncertainty has frustrated many panelists as they are trying to consider whether to support the treatment of millions of Americans.
“There is no data to show that it applies to the new variants, and I really think we need to be careful to say that this is the way to go,” said Dr. David Hardy of the Charles Drew University School of Medicine and Science, who ultimately voted for medicines .
Although Merck’s new data paints a less compelling picture of the effectiveness of the drug compared to a few weeks ago, the panel of experts has made narrow but positive recommendations.
Last week, Merck said that the final results of the study showed that compared with adults taking a placebo, monelavir reduced the hospitalization rate and mortality of adults infected with the coronavirus by 30%. This effect is significantly lower than the 50% reduction it first announced based on incomplete results.
This lower-than-expected benefit has exacerbated experts’ concerns about the drug’s toxicity to human fetuses.
FDA scientists told panel members earlier Tuesday that the company’s research on rats showed that the drug can cause toxicity and birth defects when given very high doses. In summary, the data conclusions reached by FDA staff are “indicating that monoprevir may cause harm to the fetus when administered to a pregnant individual.”
The FDA is weighing a comprehensive restriction on any use for pregnant women or allowing use in rare cases. Some panelists said that this option should be reserved for pregnant women who have high-risk COVID-19 and may have few other treatment options.
Dr. Janet Klagen, who supports the drug, said that even with strict restrictions, some pregnant women will inevitably take the drug.
A team member and staff member of the US Centers for Disease Control and Prevention said: “I think if she decides that this is what she needs, she cannot morally tell a woman with COVID-19 that she cannot take this. Kind of drugs.” “I think the final decision must be attributed to individual women and their providers.”
Merck’s drug uses a new method to fight COVID-19: It inserts a tiny error in the genetic code of the coronavirus to prevent it from replicating. This genetic effect raises concerns that the drug may stimulate more virulent strains. But the FDA regulator said on Tuesday that the risks are theoretical and seem unlikely.
Although Merck and its partner Ridgeback Biotherapeutics were the first companies to submit COVID-19 pills to the FDA, rival drugmaker Pfizer followed closely behind and is reviewing its own pills.
Pfizer’s drug is part of a decades-old family of antiviral pills, and protease inhibitors are the standard treatment for HIV and hepatitis C. Their effect is different from Merck’s pills and has nothing to do with the mutation problem caused by Merck’s drug.
Pfizer said this week that its drugs should not be affected by mutations in the omicron variant.
If authorized, the US government has agreed to purchase 10 million courses of Pfizer drugs. This is more than three times the purchase agreement between the government and Merck for 3.1 million monoprevir treatments.
Both drugs require patients to take multiple pills twice a day for five days.