EC approves Gilead's Tybost HIV boost

The European Commission approved an MAA from Gilead Sciences Inc. (NASDAQ:GILD) for Tybost cobicistat as a pharmacokinetic enhancer of protease inhibitors atazanavir and darunavir as part of antiretroviral combination therapy to treat HIV-1 infection in adults. In April, FDA issued a complete response letter for cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A; CYP3), as a boosting agent for HIV treatment with protease inhibitors (see BioCentury Extra, April 29).

Cobicistat is part of Gilead's marketed HIV drug Stribild, a once-daily tablet that also comprises elvitegravir and Truvada emtricitabine/tenofovir. Johnson & Johnson (NYSE:JNJ) markets Prezista darunavir, and Bristol-Myers Squibb Co. (NYSE:BMY) markets Reyataz atazanavir. ...