FDA Ad­Com backs Gilead­'s move to ex­pand De­scovy la­bel — but stops short of en­dors­ing broad PrEP use

Gilead is one step clos­er to un­lock­ing a po­ten­tial­ly block­buster new use of its two-drug HIV reg­i­men De­scovy — though prob­a­bly not all of it.

In a meet­ing late Wednes­day, the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 16 to 2 en­dors­ing De­scovy as a pre-ex­po­sure pro­phy­lax­is, or PrEP, in men and trans­gen­der women who have sex with men. On the ques­tion of ex­pand­ing the in­di­ca­tion to in­clude cis­gen­der women, though, a slight ma­jor­i­ty of ex­perts (10 ver­sus 8) vot­ed against it, cit­ing a lack of da­ta.

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