FDA reviewing Gilead's NDA for HIV triple therapy

Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review to an NDA for bictegravir/emtricitabine/tenofovir alafenamide to treat HIV-1 infection. Its PDUFA date is Feb. 12, 2018. Gilead said it submitted a Priority Review voucher with the NDA, but declined to say if it was the voucher the company purchased from Sarepta Therapeutics Inc. (NASDAQ:SRPT) for $125 million in February (see BioCentury Extra, Feb. 21).

In 2015, Gilead used a Priority Review voucher to speed approval of HIV drug Odefsey rilpivirine/emtricitabine/tenofovir alafenamide. It paid Knight Therapeutics Inc. (TSX:GUD) $125 million for the voucher in November 2014 (BioCentury Extra, March 2, 2016)...