In a 13-10 vote, an advisory panel recommended that the FDA approve an Emergency Use Authorization (EUA) for Merck’s antiviral drug molnupuravir for treatment of COVID. The course of treatment would be taking a pill twice a day for five days for patients with mild to moderate COVID symptoms.
The reason for the closely split vote comes from questions about the final data. In initial data, the drug was shown to reduce both death and hospitalizations by about half; however, the final data showed the risk of hospitalization and death was reduced by 30%. In fact, patients in the second half of the study were shown to have a higher risk of hospitalization or death. When questioned by the panel about this result, Dr. Nicholas Kartsonis, a Merck Vice President, was unable to provide an answer.
Other concerns from the panel included the chance of birth defects and miscarriages, as shown in animal trials. Merck has recommended against prescribing this drug to children or pregnant women.
Finally, panelists expressed concern that the antiviral could spur new mutations. The way the antiviral works is by initiating a cascade of mutations, producing errors that prevent the virus from reproducing or infecting cells. However, some panelists expressed concerned that this could lead to increasing the chance of creating new COVID variants.
The ball is now in the FDA’s and CDC’s court. They have a guarded recommendation of approval by a relatively narrow vote, with some clear concerns to consider and a reduced claim of effectiveness over what was touted earlier in the drug’s trials.
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An FDA panel supports Merck COVID drug in mixed vote
FDA advisory panel narrowly endorses Merck’s oral Covid treatment pill, despite reduced efficacy and safety questions