FDA approves fixed dose darunavir/cobicistat

24 March 2015. Related: Antiretrovirals.

Janssen press release

On 29 January 2015, the FDA approved the fixed dose of the protease inhibitor darunavir 800 mg with the PK booster (CP3A4 inhibitor) cobicistat 150 mg.

The indication is to treat HIV-1 in combination with other ARVs for treatment-naive and -experienced adults with no darunavir associated drug resistance.

The brand name for the combination is Prezcobix. Darunavir is marketed by Janssen who led this collaboration and cobicistat by Gilead.

Reference:

Janssen PR. Prezcobix (darunavir/cobicistat) approved in the U.S. for the treatment of adults living with HIV-1. (29 January 2015).
http://www.janssentherapeutics.com/news-center