CHMP recommends Evotec (atazanavir + cobicistat) for treatment of HIV-1- BMS
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evotaz (300 mg/150 mg) film coated tablets from BMS, intended for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. Evotaz is a fixed dose combination of the antiretroviral medicinal product atazanavir and the pharmacokinetic enhancer cobicistat. The active substance of Evotaz is atazanavir, an HIV-1 protease inhibitor [Antivirals for systemic use, antivirals for treatment of HIV infection, combinations (ATC code: J05AR15)].
The benefits with Evotaz are its ability to provide sustainable virological suppression if given as part of combination with other antiretroviral medicinal products for treatment of HIV-1 infection. The most frequently reported adverse reactions were ocular icterus, nausea and jaundice.
Comment: Evotec was approved by the FDA in January 2015.
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