FDA advisory panel recommends Descovy for PrEP

The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted by 16 to 2 to recommend approval of Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men, according to the drug’s developer, Gilead Sciences (Nasdaq: GILD).

“We appreciate the advisory committee’s thoughtful review and discussion of the data during today’s meeting and look forward to collaborating with FDA to make this potential new prevention option available to people at risk of HIV in the United States,” said Dr Diana Brainard, senior vice president, HIV and Emerging Viruses, at Gilead Sciences, adding: “Descovy represents a potential new therapeutic option for people at risk of sexually acquired HIV-1 infection. If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s HIV epidemic.”

Split vote on cis-gender women