HIV therapy Rezolsta approved by EC

Belgium-based Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has announced that the European Commission has approved the use of Rezolsta (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adults aged 18 years or older.

The decision 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. 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 Tybost (cobicistat) by US biotech major Gilead Sciences (Nasdaq: GILD). The darunavir and cobicistat fixed-dose combination was approved in Canada in June 2014 under the name Prezcobix, and is currently undergoing regulatory review by the US Food and Drug Administration. Janssen said it will continue to make darunavir available as a single agent in tablets.