Prezcobix from Janssen Therapeutics granted FDA approval

TITUSVILLE, N,J. — Janssen Therapeutics on Thursday announced that the Food and Drug Administration has approved its Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets. The drug is used to treat human immunodeficiency virus in combination with other antiretovirals for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, according to the company.

 

The once-daily, fixed-dose Prezcobix contains 800 mg of darunavir — marketed as Prezista in the United States — and 150 mg of cobicistat, which is a pharmockinetic enhancer (sometimes referred to as a "boosting" agent) that is developed and marketed as Tybost by Gilead Sciences. 

 

“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” said Karen Tashima, M.D., professor of medicine in the division of infectious diseases, Brown University, director of HIV Clinical Studies, Miriam Hospital, and a lead investigator in the GS-US-216-0130 study. “This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen.”