Bristol-Myers submits atazanavir/cobicistat NDA

Bristol-Myers Squibb Co. (NYSE:BMY) submitted an NDA to FDA for a fixed-dose combination of its HIV drug Reyataz atazanavir and cobicistat from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in combination with other antiretroviral agents. Gilead and BMS partnered for the fixed-dose combination in 2011.

BMS markets Reyataz, an HIV protease inhibitor. Gilead's cobicistat is approved in the EU as Tybost as a boosting agent for HIV treatment with protease inhibitors. Last year, FDA issued a complete response letter for single-agent cobicistat in the indication related to deficiencies at Gilead's Foster City, Calif., manufacturing facility. In a February 10-K, the company said it recently submitted responses to FDA regarding the deficiencies. The inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A; CYP3) is approved in the EU and U.S. as part of Gilead's Stribild, a once-daily tablet that comprises elvitegravir, cobicistat and Gilead's Truvada emtricitabine/tenofovir (see BioCentury Extra, April 29, 2013). ...