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Antimicrobial Drugs Advisory Committee

The committee discussed a supplemental new drug application (sNDA) for Descovy [emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets], submitted by Gilead Sciences, Inc. (Gilead), proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. A majority of the committee, 16 of 18 members, voted that Gilead provided substantial evidence of the safety and effectiveness of Descovy for PrEP to reduce the risk of sexually-acquired HIV-1 infection in men and transgendered women who have sex with men. A narrow majority of the committee, 10 of 18 members, voted that the data from the DISCOVER trial, in combination with the available pharmacokinetic data and other previous HIV-1 prevention trials with Truvada in cisgender women, do not allow for the expansion of the Descovy PrEP indication to include cisgender women.