Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of Rezolsta (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. 

The decision from the EC follows a Positive Opinion recommending the use of Rezolsta from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2014. At that time, the CHMP also announced two label indication extensions for darunavir, a protease inhibitor marketed as Prezista by Janssen, which have also been approved by the EC.

Rezolsta is a new once-daily, fixed-dose combination tablet containing darunavir and the pharmacokinetic enhancing or "boosting" agent cobicistat (marketed as Tybost by Gilead Sciences, Inc.). The Janssen marketing authorization application was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents, and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations. The tolerability profile of the fixed dose-combination is similar to that of the two agents taken separately.

For more details, go to: http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=884826