(CN) — An expert panel voted 13-10 Tuesday recommending the U.S. Food and Drug Administration grant emergency use authorization to a new drug developed by Merck to treat mild to moderate Covid-19 in unvaccinated patients.
Following this hurdle, the FDA will likely issue a formal decision on emergency authorization of the molnupiravir pill within days. Further investigation would be needed to grant the medication full FDA approval.
In a recent study on 1,433 participants, Merck claimed the drug reduced the risk of death from Covid in unvaccinated patients by 3%, and relative risk by 30% compared to the control group. The report indicated nine people died in the placebo group, compared to one in the group that received the drug.
Delivered orally in pill form, molnupiravir contains a strong ribonucleoside that prevents the SARS-CoV-2 virus from replicating. The drug shows the most promise when taken within five days of the onset of symptoms, particularly among patients who are older than 60.
The United Kingdom approved the drug in early November. This past June, the U.S. government committed $1.2 billion to purchase 1.7 million courses of the drug. According to a statement, Merck anticipated manufacturing 10 million treatment courses by the end of the year.
The Antimicrobial Drugs Advisory Committee of 23 health professionals weighed in on whether the known benefits of the drug outweigh the known risks of the drug for patients at high risk of severe Covid, hospitalization or death.
Except in extremely narrow circumstances, the panel advised against giving molnupiravir to pregnant or lactating women.
“What this comes down to for me is do we want to reduce the risk for the mother by 30% of harm while exposing the embryo and fetus to a much higher risk of harm by this drug? And the answer is no, there’s no circumstances in which I would advise a pregnant woman to take this drug,” Dr. James Hildreth told the panel.
The panel additionally discussed the risks the medication transpiring mutations of the coronavirus that causes Covid-19.
“A week ago when this analysis was completed by the FDA, it was difficult to imagine that SARS-CoV-2 could do such large evolutionary jumps and go through such mutations. This week now that we know about the omicron variant, we cannot dismiss this evidence,” said Rustem Ismagilov, a professor of bio and medical engineering at CalTech, during the public comment period.
Several members of the panel agreed more research is needed to see if the drug increased viral mutations. Others said if the medication successfully decreases viral load and patients agree to quarantine during treatment, those risks could likely be mitigated.
“There is a theoretical concern for enhanced viral evolution, however there’s no evidence that the emergence of spike protein amino acid changes affected virological clinical outcomes for patients with Covid-19,” said Dr. Debra Birnkrant, the director of the Division of Antivirals.
The ticking clock ultimately weighed heavily on many panel members, who discussed the issued from 9 a.m. Eastern until just after 5 p.m., with the understanding the medical community needs readily available Covid treatments in the face of the highly transmissible delta and omicron variants.
"I see this is an incredibly difficult decision and as has already been stated there are many, many more questions than answers," said Dr. Lindsey Baden, who led the discussion. "However, I see the regulatory framework [asking]: are there circumstance where the benefit may exceed the risk? And I think I found the mortality data compelling."
Baden added the FDA, Merck, and the medical community need to specify the narrow population that will benefit most from molnupiravir and continue to study its efficacy against emerging viral variants.
The FDA has other treatments to approve as well. Pfizer has asked the FDA to approve the Paxlovid antiviral pill, a protease inhibitor that operates similarly to HIV treatment, for emergency use.
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