EMA Panel Recommends Evotaz for Adults With HIV-1

Troy Brown, RN

Disclosures

May 22, 2015

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended granting marketing authorization for atazanavir/cobicistat (Evotaz, Bristol-Myers Squibb Pharma EEIG) for the treatment of adults with HIV-1 infection and no known mutations associated with atazanavir resistance, according to an agency news release. It is intended to be given with other antiretroviral medicinal products.

Atazanavir is an HIV-1 protease inhibitor, and cobicistat is a pharmacokinetic enhancer. The two drugs are combined in 300 mg/150 mg film-coated tablets.

Atazanavir/cobicistat provides sustainable virological suppression when given together with other antiretroviral medications to treat HIV-1 infection.

The adverse reactions most commonly reported were ocular icterus, nausea, and jaundice.

The committee recommends that atazanavir/cobicistat be prescribed by physicians experienced in the management of patients with HIV infection.

The summary of product characteristics will provide detailed recommendations for the product's use and will be published in the European public assessment report. The document will be available in all official languages of the European Union after the European Commission grants marketing authorization.

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