EU approves Evotaz (atazanavir + cobicistat) to treat HIV-1- BMS

BMS has announced that the European Commission has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. Coformulated to be one pill, once-daily Evotaz combines the protease inhibitor atazanavir, which is marketed as Reyataz, and cobicistat, a pharmacokinetic enhancer marketed as Tybost by Gilead Sciences, Inc. This approval allows for the marketing of Evotaz in all 28 Member States of the European Union (EU) and offers patients living with HIV a treatment option that delivers proven suppression through 144 weeks.

The marketing authorization follows a positive opinion by the Committee for Medicinal Products for Human Use in May 2015. The FDA approved Evotaz in the United States in January 2015. Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to the active substances or to any of the excipients of Evotaz, in combination with certain drugs, and in patients with moderate to severe hepatic impairment. Evotaz and Reyataz do not cure HIV-1 infection or AIDS.