A Food and Drug Administration (FDA) panel voted 13-10 that the benefits of the drug mollupiravir, including potential birth defects, outweigh its risks when used during pregnancy.
A panel of US health advisors backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for possible authorization of the first drug that Americans could take at home to treat the virus.
A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits, including potential birth defects, outweigh its risks when used during pregnancy.
The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts who support the treatment stressed that it should not be used by anyone who is pregnant and that the FDA advises taking extra precautions before prescribing the drug, including for women of child-bearing age. Including pregnancy test.
The vote specifically favored the drug for adults with mild to moderate COVID-19, who face the greatest risk, including older people and those with conditions such as obesity and asthma. Most experts also said that the drug should not be used in vaccinated patients who were not part of the study and the drug has not been shown to benefit.
The FDA is not bound by the panel’s recommendation and is expected to make its decision before the end of the year.
The drug could provide a much-needed weapon against the virus as the number of cases swells during cold weather and US officials prepare for the arrival of the new Omicron version. It is already authorized for emergency use.
Merck has not specifically tested its drug against the new version, but has said it should have some potency based on its effectiveness against other strains of the coronavirus.
But that uncertainty left many panelists as they grappled with whether to support the treatment for millions of Americans.
David Hardy from the Charles Drew University School of Medicine and Science said, “There is no data saying it works with the new forms, I really think we should be careful saying this is the way to go. ” Medicine.
The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than it did a few weeks ago.
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