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Aug. 5 Company Quick Takes: Briefing docs for Descovy cast doubt on full PrEP approval; plus Alnylam, Provention and more

August 5, 2019 11:52 PM UTC

FDA questions Descovy as PrEP in cis women
Briefing documents released ahead of the Aug. 7 Antimicrobial Drugs Advisory Committee meeting for Descovy emtricitabine/tenofovir alafenamide from Gilead Sciences Inc. (NASDAQ:GILD) indicate that FDA is uncertain whether data support the candidate's efficacy as pre-exposure prophylaxis (PrEP) in cisgender women. The Phase III DISCOVER trial, upon which Descovy's sNDA is based, was conducted in men and transgender women who have sex with men. Gilead is looking to Descovy as a successor to its Truvada emtricitabine/tenofovir for PrEP to reduce the risk of sexually acquired HIV-1 infection (see "Gilead Sees Descovy as Successor to Truvada").

Priority Review for Alnylam's givosiran
Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said FDA accepted and granted Priority Review to an NDA for givosiran to treat acute hepatic porphyria. The ALAS-targeting RNAi therapy has a PDUFA date of Feb. 4, 2020...