FDA OKs BMS, Gilead HIV Combo Drug

The US Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz is coformulated to be one pill, once-daily, combining Bristol-Myers Squibb’s protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc.

In October 2011, Bristol-Myers Squibb formed a licensing agreement with Gilead for the development and commercialization of a once-daily, fixed-dose combination product of atazanavir and cobicistat, now named Evotaz. Under the agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution, and commercialization of the Evotaz fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development, and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

Source: Bristol-Myers Squibb

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