Merck Seeks FDA Approval for Pill to Treat Covid-19
It was announced this morning that Merck is seeking approval from the US Food and Drug Administration for emergency use authorization for it’s experimental antiviral Covid-19 pill Molnupiravir. If the authorization is granted, it would be the first oral antiviral treatment to fight Covid-19. Merck said it’s asking for authorization to use the pill to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization. Their submission is based on a study that was stopped at the interim point because the drug was working so well in over 700 patients randomly assigned to take the drug or a placebo.
The company said “at the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50%” and added “through day 29 of the study, no deaths were reported in patients who received Molnupiravir, compared to eight deaths in patients who received placebo.” None of the volunteers in the trial had been vaccinated. Merck expects to produce 10 million courses of the treatment by the end of 2021 if approved and more courses will be produced in 2022. It has already sold 1.7 million treatment courses to the US government.