If authorization is granted, the drug would be the first oral antiviral treatment to fight COVID-19. It comes in capsule form.
Merck said Monday it is seeking US Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.
Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.
"Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo." None of the volunteers in the trial had been vaccinated. It has already sold 1.7 million treatment courses to the US government. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.
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