EU approves Gilead's elvitegravir

The European Commission approved an MAA from Gilead Sciences Inc. (NASDAQ:GILD) for Vitekta elvitegravir to treat HIV-1 infection in adults without known mutations associated with resistance to elvitegravir. The HIV integrase inhibitor is approved for use in combination with an HIV regimen that includes a ritonavir-boosted protease inhibitor. Gilead has ex-Japanese rights to elvitegravir from Japan Tobacco Inc. (Tokyo:2914).

Elvitegravir is a component of Gilead's HIV drug Stribild, a once-daily tablet already approved in the U.S. and EU. Stribild comprises elvitegravir, cobicistat and Gilead's Truvada emtricitabine/tenofovir. In April, FDA issued a complete response letter for both elvitegravir and cobicistat as single agents (see BioCentury Extra, April 29). ...