EU approval for Bristol-Myers' HIV drug Evotaz

16 July 2015

The European Commission has approved US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Evotaz (atazanavir 300mg and cobicistat 150mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Co-formulated to be one pill, once-daily, Evotaz combines the protease inhibitor atazanavir, which is marketed as Reyataz capsules, and cobicistat, a pharmacokinetic enhancer marketed as Tybost by Gilead Sciences (Nasdaq: GILD). The approval allows for the marketing of Evotaz in all 28 member states of the European Union and offers patients living with HIV an innovative treatment option that delivers proven suppression through 144 weeks.

The marketing authorization follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2015. The US Food and Drug Administration approved Evotaz earlier this year.

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