Un­per­suad­ed by the da­ta, FDA re­jects cheap, gener­ic SS­RI as a Covid-19 drug

Flu­vox­am­ine, an SS­RI al­ready FDA-ap­proved as an OCD treat­ment, ap­peared to show some hints of ef­fi­ca­cy in Covid-19 too, lead­ing Uni­ver­si­ty of Min­neso­ta ID doc David Boul­ware last De­cem­ber to sub­mit an EUA for it as an out­pa­tient treat­ment for those test­ing pos­i­tive and to pre­vent the pro­gres­sion to hos­pi­tal­iza­tion.

Al­most 6 months lat­er, the FDA said Mon­day it’s re­ject­ing the cheap gener­ic drug’s Covid-19 EUA as the pri­ma­ry RCT from Brazil, on which the ma­jor­i­ty of the app rests: “The treat­ment ben­e­fit of flu­vox­am­ine was not per­sua­sive when fo­cus­ing on clin­i­cal­ly mean­ing­ful out­comes such as pro­por­tion of pa­tients ex­pe­ri­enc­ing hos­pi­tal­iza­tions or hos­pi­tal­iza­tions and deaths.”

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