Aug. 7 Company Quick Takes: Panel backs narrower PrEP label for Descovy; plus Teva, Blueprint, DBV and more

FDA panel backs narrower PrEP label for Descovy

FDA’s Antimicrobial Drugs Advisory Committee voted 16 to 2 that Gilead Sciences Inc. (NASDAQ:GILD) has provided sufficient evidence that Descovy emtricitabine/tenofovir alafenamide is safe and effective for pre-exposure prophylaxis (PrEP) to reduce sexually acquired HIV-1 infection in men and transgender women. In an 8 to 10 vote, the panel rebuffed the therapy for use in cisgender women. Briefing documents released ahead of the meeting indicated that FDA reviewers were uncertain whether data supported the candidate's efficacy in the population (see “Gilead Sees Descovy as Successor to Truvada for HIV PrEP”)...