Panel Backs Descovy for Preventing HIV in Men

FDA’s Antimicrobial Drugs Advisory Committee has voted 16-2 to recommend approval for Gilead Sciences’ HIV drug Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men. Panel members were mixed in a 8 to 10 vote, however, on whether the combination therapy should be approved in cisgender (sex at birth) women for PrEP.

For cisgender women, panel members said a lack of data in the population was concerning. The company’s Phase 3 Discover trial enrolled only transgender women and cisgender men who have sex with men, and panel members were not comfortable extrapolating data to apply to cisgender women. They also urged FDA to require Gilead to conduct post-marketing studies in cisgender women.

Descovy was approved 4/2016 for treating HIV-1 infection in adults and pediatric patients in combination with other antiretroviral agents.