More than a year after its emergency authorization, FDA fully approves Pfizer's Covid pill Paxlovid for adults
More than 510 days since first earning an emergency use authorization, Pfizer’s life-saving Covid-19 pill Paxlovid (nirmatrelvir and ritonavir) finally won full FDA approval on Thursday for the treatment of mild-to-moderate Covid for adults who are at high risk for progression to severe Covid, including hospitalization or death.
The full approval, which was expected, was primarily based on the final results of the EPIC-HR clinical trial, which controversially included only patients who were unvaccinated and had not been previously infected with Covid. FDA said an analysis of the results showed that of the 977 patients who received Paxlovid, and 989 patients who received placebo, 0.9% on Paxlovid were hospitalized due to Covid-19 or died from any cause during 28 days of follow-up, compared to 6.5% of those on placebo.
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