Complete response for Gilead's cobicistat, elvitegravir

Gilead Sciences Inc. (NASDAQ:GILD) said it received complete response letters from FDA for a pair of NDAs for elvitegravir and cobicistat. Gilead was seeking approval of elvitegravir to treat HIV-1 infection in treatment-experienced adults and approval of cobicistat as a boosting agent for HIV treatment with protease inhibitors. According to the company, FDA said there were deficiencies in the documentation and validation of quality testing procedures and methods during recent inspections. Gilead said it is working with FDA to address the questions but declined to provide details.

Elvitegravir, an HIV integrase inhibitor, and cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), are part of Gilead's Stribild, a once-daily tablet that comprises elvitegravir, cobicistat and Gilead's Truvada emtricitabine/tenofovir. FDA approved the regimen last August to treat HIV-1infection in treatment-naïve adults. Gilead said the complete response letters do not affect Stribild's marketing authorization. ...