Janssen files new NDA for combination HIV drug containing darunavir

1 April 2014

US health care giant Johnson & Johnson’s (NYSE: JNJ) Europe-based subsidiary Janssen has submitted a New Drug Application to the US Food and Drug Administration for a once-daily fixed-dose antiretroviral combination tablet containing darunavir (Prezista in the USA), with cobicistat, an investigational pharmacokinetic enhancer developed by US biotech major Gilead Sciences (Nasdaq: GILD) for use in combination with other HIV medicines.

Prezista is indicated for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. Prezista 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, for the first time, offer an additional therapeutic option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.

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