FDA to again review Gilead's cobicistat, elvitegravir

FDA accepted for review two resubmitted NDAs from Gilead Sciences Inc. (NASDAQ:GILD) for cobicistat and elvitegravir. Cobicistat is under review as a boosting agent for HIV treatment with protease inhibitors, with an Oct. 3 PDUFA date. Elvitegravir is under review to treat HIV-1 infection in treatment-experienced adults, with an Oct. 4 PDUFA date. FDA issued complete response letters for both compounds last year (see BioCentury Extra, April 29, 2013).

Cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), is approved as Tybost in the EU, Canada and Australia. Elvitegravir, an HIV integrase inhibitor, is approved as Vitekta in the regions. Both compounds are also part of Gilead's Stribild, a once-daily tablet approved in the U.S. and EU for HIV-1 infection in treatment-naïve adults. ...