FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With lit­tle ex­pla­na­tion for why Mer­ck’s po­ten­tial Covid-19 an­tivi­ral was less ef­fec­tive in re­duc­ing Covid hos­pi­tal­iza­tions and deaths in a full analy­sis of a Phase III tri­al ver­sus an in­ter­im look, the FDA’s an­timi­cro­bial drugs ad­vi­so­ry com­mit­tee on Tues­day vot­ed 13-10 in fa­vor of the pill’s ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms.

Mol­nupi­ravir will like­ly be au­tho­rized by FDA in the com­ing days for adults with mild or mod­er­ate Covid-19. While Pfiz­er’s an­tivi­ral may prove to be more ef­fec­tive, Mer­ck’s pill will be an­oth­er weapon in the ar­ma­men­tar­i­um of Covid-19 treat­ments for coun­tries around the world, adding to the mAb treat­ments al­ready in use in the out­pa­tient space from Re­gen­eron, Eli Lil­ly and Vir/Glax­o­SmithK­line.

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