Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

FDA re­jects Gilead’s next big HIV drug over glass vial is­sues

Gilead on Tues­day re­ceived a re­jec­tion let­ter for its lat­est po­ten­tial first-in-class HIV drug, as the com­pa­ny said the FDA cit­ed Chem­istry Man­u­fac­tur­ing and Con­trols (CMC) is­sues re­lat­ing to the com­pat­i­bil­i­ty of lenaca­pavir with its pro­posed con­tain­er vial.

Reg­u­la­tors pre­vi­ous­ly slapped a clin­i­cal hold on 10 tri­als study­ing in­jectable ver­sions of the ex­per­i­men­tal HIV treat­ment, known as lenaca­pavir, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of sub-vis­i­ble glass par­ti­cles in the so­lu­tion.

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