EC OKs BMS’ HIV Combo DrugBy
The European Commission has approved Bristol-Myers Squibb’s 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 Bristol-Myers Squibb’s protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir) capsules, and cobicistat, a pharmacokinetic enhancer marketed as Tybost by Gilead Sciences, Inc.
The approval by the European Commission allows for the marketing of Evotaz in all 28 member States of the European Union. The marketing authorization follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use in May 2015. The US Food and Drug Administration (FDA) approved Evotaz in the United States in January 2015.
Bristol-Myers Squibb and Gilead formed a licensing agreement in October 2011 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.
Reyataz, which contains one of the active ingredients in the newly approved Evotaz, is one of Bristol-Myers Squibb’s top-selling drug. In 2014, Reyataz posted revenues of $1.36 billion.
Source: Bristol-Myers Squibb