HIV/AIDS Update - Prezcobix tablet containing 800 mg of darunavir and 150 mg of cobicistat approval

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Thu, 29 Jan 2015 16:40:48 -0600

Title:     HIV/AIDS Update - Prezcobix tablet containing 800 mg of darunavir and 150 mg of cobicistat approval

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  On January 29, 2015, FDA approved Prezcobix a fixed dose combination tablet containing 800 mg of darunavir and 150 mg of cobicistat.
Prezcobix is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). The recommended dosage of Prezcobix is one tablet taken once daily orally with food.
Darunavir exposure when comparing darunavir coadministered with cobicistat (as single entities) to darunavir coadministered with ritonavir was evaluated in a relative bioavailability trial in 31 healthy subjects. The results of the trial are presented in the cobicistat package insert. With the exception of Ctau, the steady-state pharmacokinetic parameters of darunavir were comparable when coadministered with cobicistat versus ritonavir and these results were similar to those reported in previous clinical trials of darunavir 800 mg with ritonavir 100 mg once daily.
The efficacy of Prezcobix is based on efficacy demonstrated in clinical trials of darunavir coadministered with ritonavir. One single arm clinical trial was conducted with darunavir and cobicistat administered as single entities in 313 HIV-infected subjects. Adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir coadministered with ritonavir.
Prezcobix is a product of Janssen Pharmaceuticals.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

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