news: The US Food and Drug Administration panel voted 13-10 to recommend that the government authorize Merck’s antiviral pill for patients with early COVID-19 and at risk of severe infection. The drug, called molonoperavir, has been shown to reduce the risk of hospitalization and death, although it is lower than previously thought. Preliminary results in October found it reduced the risk of hospitalization or death by 50% when given to 755 unvaccinated volunteers who had mild to moderate disease with COVID-19 and had at least one risk factor for severe disease. Last week, with updated data from 1,433 patients, that number was reduced to 30%. “The efficacy of this product is not significantly good,” said panel member David Hardy.
No consensus: The convergence in the vote was due to concerns about the change in the drug’s efficacy data, but also about its safety. James Heldreth, CEO of Mahari Medical College and a member of the committee, She said He voted “no” because he was concerned that use of molonoperavir, in theory, could lead to new variants of covid-19. However, other members of the committee argued that the overall risk was small enough to be voted on.
Who can take it: If the drug is licensed, it will be prescribed to high-risk people who are beginning to have symptoms by taking it twice daily at home for five days. Tens of millions of Americans who are older or have underlying medical conditions will qualify and need to start taking them within five days of symptoms appearing. The Committee recommended strict restrictions on the use of molnopiravir in pregnant women, given concerns about possible side effects.
What then: In the coming weeks, the FDA will evaluate a similar pill from Pfizer that appears to be significantly more effective than Merck’s, reducing the risk of hospitalization or death within the same patient groups by 89%. The hope is that these drugs can provide promising new weapons in our arsenal against Covid, especially because they can be easily stored and taken at home. The US government has already spent billions of dollars securing significant supplies of both new pills.