Voucher speeds approval of Gilead/J&J HIV regimen

FDA approved an NDA for Odefsey rilpivirine/ emtricitabine/tenofovir alafenamide (R/ F/TAF) to treat HIV-1 infection in antiretroviral-naive patients aged 12 and older with HIV-1 RNA levels ≤100,000 copies per mL, and as a replacement for a stable antiretroviral regimen in virologically suppressed HIV patients who meet certain qualifications.

Gilead Sciences Inc. (NASDAQ:GILD) used a Priority Review voucher to speed the NDA's review. In November 2014, the company paid Knight Therapeutics Inc. (TSX:GUD) $125 million for the voucher, which was issued under FDA's tropical disease program (see BioCentury Extra, Nov. 19, 2014). ...