Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

Japan Tobacco said the Japanese Ministry of Health, Labor and Welfare (MHLW) approved its NDA for Stribild to treat HIV-1 infection. Japan Tobacco's subsidiary Torii Pharmaceutical Co. Ltd. (Tokyo:2914; Osaka:2914, Tokyo, Japan) has exclusive commercialization rights to the product in Japan. Last August, FDA approved an application from Gilead for the once-daily tablet comprising elvitegravir, cobicistat and Gilead's HIV drug Truvada emtricitabine/tenofovir to treat HIV-1 infection in treatment-naïve adults. The product is also approved in Canada, South Korea and Australia, and is under review in Europe.

Elvitegravir, an HIV integrase inhibitor, is under review as a single agent in the U.S. and EU to treat HIV-1 infection in treatment-experienced adults. Cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), is under review as a single agent as a boosting agent for HIV treatment with protease inhibitors. Elvitegravir has an April 27 PDUFA date, while cobicistat has an April 28 PDUFA date. Gilead markets Truvada, a fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir disoproxil fumarate, which Japan Tobacco markets in Japan. ...