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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