FDA Panel Issues Split-Decision for Gilead’s HIV Prevention Drug

The FDA’s Antimicrobial Drugs Advisory Committee voted Wednesday to recommend Gilead Sciences’ supplemental NDA for Descovy (emtricitabine and tenofovir alafenamide ) for prevention of  HIV-1 infections in men and transgender women — but shot down the drug for use in cisgender women.

The committee voted 16-2 in favor of the sNDA for pre-exposure prophylaxis (PrEP) for men and transgender women and 10-8 against the indication for cisgender women.

The committee considered the results of the DISCOVER trial, which compared the efficacy of the drug to Truvada (emtricitabine and tenofovir disoproxil fumarate).