Janssen's HIV Pill Rezolsta Approved In EU

Johnson & Johnson company Janssen-Cilag announced the approval of the European Commission for Rezolsta (darunavir/cobicistat) as treatment for human immunodeficiency virus-1 (HIV-1) infection in patients 18 years and above in the EU.

Rezolsta is a once daily, fixed-dose combination (FDC) tablet comprising Janssen’s darunavir and Gilead Sciences’ pharmacokinetic booster cobicistat. Darunavir is a protease inhibitor which can be taken with either cobicistat or ritonavir. Cobicistat (marketed as Tybost) boosts blood levels of darunavir by suppressing the enzyme CYP3A that metabolizes the drug in the body.

The EC approved Rezolsta in combination with other antiretroviral (ARV) drugs as treatment for HIV-1. The approval was supported by positive bioequivalence data which assessed Rezolsta’s safety and efficacy against single agents. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) already recommended the approval of Rezolsta in September this year. The Committee also backed Janssen’s application for two label indication extensions for darunavir as a single agent, which was also subsequently approved by the EC.

HIV has affected nearly 75 million since it first spread as an epidemic. Approximately 35 million people around the world today are living with HIV, with 2.5 million newly infected every year. Dr. Christiane Moecklinghoff, Medical Director of Virology at Janssen EMEA, praised the approval as a step forward for patients with HIV. “Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. Rezolsta eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients.”

The company said the combination treatment is presently undergoing regulatory review by the U.S. Food and Drug Administration (FDA). Earlier this year, Janssen collaborated with GlaxoSmithKline company ViiV Healthcare to develop another combination treatment targeting HIV-1. The companies agreed to develop Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) with HIV-1 integrase strand transfer inhibitor (INSTI) Tivicay (dolutegravir).