Janssen's Rezolsta For HIV Backed By CHMP
Janssen-Cilag International announced that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Rezolsta (darunavir/cobicistat) for use with other antiretroviral therapies against human immunodeficiency virus-1 (HIV-1) infection in adult patients.
Rezolsta is a once-daily fixed-dose combination tablet comprised of darunavir and its booster agent cobicistat. Darunavir is a protease inhibitor used to treat HIV-1 infection, which is marketed by the company as Prezista. Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor marketed under the brand name Tybost by Gilead Sciences. The combination therapy was recently approved in Canada as Prezcobix. The U.S. Food and Drug Administration (FDA) is also currently reviewing the drug.
Dr. Christiane Moecklinghoff, Medical Director of Virology at Janssen EMEA, said, “If approved, this new treatment option eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients. We look forward to a final decision from the European Commission in the coming months.”
The European regulatory submission was supported by the positive bioequivalence data as well as safety and efficacy results from a clinical study of the combo therapy in patients with HIV-1 who are not resistant to darunavir.
HIV has afflicted nearly 75 million people since its outbreak. An estimated 35 million are living with HIV today, with 2.5 new infections occurring every year. “People with HIV are living longer than ever before thanks to the development and introduction of effective HIV treatments. For this reason, expanding existing treatment options, especially those which will improve patients' lives by simplifying regimens and supporting adherence are critical,” added Dr. Moecklinghoff.
In addition, the CHMP also issued two label extensions for Prezista (darunavir) to include co-administration with cobicistat and to open up the drug for children ages 3 and up.