Janssen's Prezcobix approved for HIV in the USA

The US Food and Drug Administration has approved Prezcobix (darunavir 800mg/cobicistat 150mg) tablets, manufactured by Janssen, a subsidiary of Johnson & Johnson (NYSE: JNJ) for the treatment of HIV.

The HIV-1 protease inhibitor combined with a CYP3A4 inhibitor has been approved for the treatment of human immunodeficiency virus in combination with other antiretroviral agents for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions.

Karen Tashima, lead investigator in the GS-US-216-0130 study of Prezcobix, said: “Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease. 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.”