CHMP recommends Rezolsta combination darunavir + cobicistat for HIV treatment - Janssen Cilag

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rezolsta (800 mg/150 mg), film-coated tablet intended for the treatment of antiretroviral therapy (ART)-na�ve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs). The applicant for this medicinal product is Janssen-Cilag International N.V.

Rezolsta is a fixed-dose combination of the antiretroviral medicinal product darunavir and the pharmacokinetic enhancer cobicistat. The active substance of Rezolsta is darunavir, an HIV-1 protease inhibitor. A pharmacovigilance plan for Rezolsta will be implemented as part of the marketing authorisation.