An experimental COVID-19 antiviral drug called molnupiravir from Merck & Co. and Ridgeback Biotherapeutics are under review by the Food and Drug Administration for emergency use during the pandemic.
Merck & Co Inc / REUTERS phát Handout
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A panel of expert advisors to the Food and Drug Administration voted in favor of the emergency use authorization of Merck and Ridgeback Biotherapeutics’ antiviral drugs to treat COVID-19.
The number of votes is 13 for and 10 votes against permission. The FDA is not required to follow its advisors’ recommendations, but it usually does.
If the agency authorizes the use of the drug, called molnupiravir, it would be the first oral COVID-19 antiviral treatment that can be given at home. A second Pfizer oral drug, called Paxlovid, is also under FDA review.
Merck is given twice a day for five days and works by inducing a series of mutations that disable the SARS-CoV-2 virus during replication. The drug is indicated for use in people with mild to moderate illness and those at high risk for severe COVID-19. It is supposed to be taken within five days of symptoms.
An interim analysis of a drug clinical study found that molnupiravir halved the risk of hospitalization or death. Among those taking the drug, 7.1% required hospitalization or death compared with 14.1% of those taking a placebo. However, the final study analysis published on Friday found that the risk of hospitalization or death was reduced by only 30%.
An FDA summary found that in the second half of the study, patients in the group treated with the drug were more likely to be hospitalized or die than those given a placebo. The drug’s protection against death seen in the first half of the study was not maintained in the second half.
Asked about this distinction by the committee chair, Dr. Lindsey Baden, Dr. Nicholas Kartsonis, Merck’s senior vice president, said, “I don’t have a satisfactory answer to your question.”
The drug’s extraviral mutagenicity, as seen in several laboratory and animal tests, raised a number of safety issues that were discussed during the day-long meeting. The possibility of birth defects weighed heavily on the team, and there were reservations about prescribing the drug to pregnant women. But drugs may also offer some benefits to them.
“I don’t think you can morally say that it’s OK to use this drug during pregnancy,” said Dr Janet Cragan of the Centers for Disease Control and Prevention. “But at the same time, I’m not sure you can morally say to a pregnant woman with COVID-19 that she can’t have the medication if she decides it’s what she needs.”
There are also concerns about whether the drug could cause harmful mutations in the virus’s mutant protein, which is the target of the widely used COVID-19 vaccine around the world.
During the panel discussion, John Coffin, a virologist at Tufts University, said that random mutation rates as high as those seen in molnupiravir were a relatively small factor in the development of variables. worrisome virus.
Some panelists called for more research on the drug in people with compromised immune systems to look for changes in the virus after they were treated with the drug.
