Tybost cobicistat regulatory update

FDA accepted for review 2 resubmitted NDAs from Gilead for cobicistat and elvitegravir. Cobicistat is under review as a boosting agent for HIV treatment with protease inhibitors atazanavir and darunavir, 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. According to the company, FDA said there were deficiencies in the documentation and validation of quality testing procedures and methods during recent inspections (see BioCentury, May 6, 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. ...