The US Food and Drug Administration (FDA) Committee of Health Experts voted on November 30 to support the approval of Merck's new coronavirus pneumonia (COVID-19) oral drug Molnupiravir for emergency use.
The FDA does not have to follow the committee's recommendations, but it usually does.
If the FDA approves it for emergency use, it will be the only oral drug for new coronary pneumonia available on the market so far.
The course of treatment of monapilavir is 5 days, and the patient must take 2 pills a day.
It will cause the new coronavirus to undergo a series of mutations that cause it to fail when it replicates.
The goal of this medicine is to use people with mild and mild symptoms, but who are likely to become severely ill.
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Experts have doubts
13 members of the committee voted for it and 10 opposed it.
The number of votes closely reflects some members' concerns about new drugs.
Some people are concerned about its effect on people of fertile age, and some question the possibility that drugs can drive the virus to mutate.
Studies using monapiravir in animals have shown that it may have an adverse effect on the development of fetal bones.
The drug company has not yet tested it on pregnant women.
The data provided by the company is also one of the reasons why experts are uneasy.
The pharmaceutical company pointed out in the mid-term analysis of clinical trials that monapiravir can reduce the risk of hospitalization and death by 50%-among those taking the drug, 7.1% were admitted to the hospital or died; among those taking a placebo, 14.1% .
However, the final analysis released on November 26 said that it can only reduce the risk of hospitalization or death by 30%.
Is it effective for Omicron?
The outside world is most concerned about the effectiveness of the oral drug against the new mutant virus Omicron. An employee of Merck said that based on evidence that it is effective against other mutant virus strains such as Delta, Mu, and Lambda, a Merck said the drug should be effective against Omicron. .
However, the staff also said that the company has not yet completed a trial for Omicron.
In addition, the oral drug Paxlovid developed by the US pharmaceutical company Pfizer is still subject to FDA's consideration and approval.
