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Janssen Seeks Approval for Combination HIV Therapy

Darunavir and cobicistat tablet would eliminate need for separate boosting agent

Janssen Research & Development has submitted a new drug application (NDA) to the FDA for a once-daily fixed-dose antiretroviral combination tablet containing Prezista (darunavir, Janssen) and cobicistat (Gilead Sciences). Darunavir is a protease inhibitor, while cobicistat is an investigational pharmacokinetic enhancer. The tablet would be used in combination with other human immunodeficiency virus (HIV-1) medicines.

Once-daily darunavir, the most prescribed HIV protease inhibitor in the U.S., is indicated for the treatment of HIV-1 in treatment-naive and treatment-experienced adults with no darunavir resistance-associated mutations. It is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines.

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.

In June 2011, Janssen announced a license agreement with Gilead for the development and commercialization of a once-daily tablet fixed-dose combination product of darunavir and cobicistat. While Janssen will handle the fixed-dose combination worldwide, Gilead will retain sole rights over cobicistat as a stand-alone product and for use in combination with other agents.

Source: Jannsen Research & Development; April 1, 2014.

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