Janssen submits darunavir/cobicistat NDA

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) submitted an NDA to FDA for a fixed-dose combination of J&J's HIV drug darunavir and cobicistat from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in adults in combination with other HIV-1 drugs. Gilead and J&J partnered to develop and commercialize the combination, which is also under review in the EU, in 2011 (see BioCentury Extra, June 28, 2011).

J&J markets darunavir as Prezista. Gilead's cobicistat is approved in the EU as Tybost. FDA issued a complete response letter for cobicistat last year (see BioCentury Extra, April 29, 2013). ...