NDA Submitted for Combination HIV-1 Therapy
Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA for Prezista (darunavir) with cobicistat (Gilead Sciences) for use in combination with other human immunodeficiency virus (HIV-1) drugs. Darunavir, a protease inhibitor and cobicistat, a pharmacokinetic enhancer or boosting agent is a once-daily fixed-dose antiretroviral combination tablet.
If approved, the fixed-dose combination tablet will be marketed under a new brand name and will offer an additional therapeutic option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.
Prezista is already approved for the treatment of HIV-1 in combination with ritonavir and with other antiretroviral agents in treatment-naïve and treatment-experienced patients.