Rezolsta darunavir/cobicistat regulatory update
EMA's CHMP recommended approval of Rezolsta darunavir/cobicistat to treat HIV-1 infection in combination with other antiretroviral drugs in adults. The product is a once-daily fixed-dose combination of HIV drugs Prezista darunavir from Johnson & Johnson and Tybost cobicistat from Gilead. J&J's Janssen Research & Development LLC unit launched the combination last month in Canada under the name Prezcobix. In April, Janssen said it submitted an NDA to FDA for the combination. Gilead and J&J partnered to develop and commercialize the combination in 2011 (see BioCentury, July 4, 2011).
Gilead's Tybost is approved in the EU as a pharmacokinetic enhancer of protease inhibitors atazanavir and Prezista as part of an antiretroviral combination therapy to treat HIV-1 infection in adults. Cobicistat is an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A; CYP3). Darunavir is a second-generation protease inhibitor. ...