Janssen Therapeutics, a division of Janssen Products, LP and part of Johnson & Johnson, reports that the US Food and Drug Administration (FDA) has approved (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions.

Prezcobix is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as Prezista PREZISTA® in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or “boosting” agent, developed and marketed as Tybost® by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food.

Source: Johnson & Johnson