Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

EMA's CHMP issued a positive opinion recommending approval of an MAA from Gilead for Stribild to treat HIV-1 infection in treatment-naïve adults. FDA approved Stribild - a once-daily tablet comprising elvitegravir, cobicistat and Gilead's HIV drug Truvada emtricitabine/tenofovir, a fixed-dose combination of two nucleoside analog reverse transcriptase inhibitors (NRTIs) - for the indication last August. The product is also approved in Canada, South Korea and Australia, and is under review in Japan.

Elvitegravir, an HIV integrase inhibitor, is under review as a single agent in the U.S. and EU to treat HIV-1 infection in treatment-experienced adults. Cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), is under review as a single agent as a boosting agent for HIV treatment with protease inhibitors. Elvitegravir has an April 27 PDUFA date, while cobicistat has an April 28 PDUFA date. ...