Janssen-Cilag files European approval of combination medicine for HIV-1

16 October 2013

US health care giant Johnson & Johnson (NYSE: JN) subsidiary Janssen-Cilag International NV has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product.

The single tablet contains darunavir, a protease inhibitor developed by Janssen, with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by US biotech firm Gilead Sciences (Nasdaq: GILD) for use in combination with other HIV-1 medicines.

Once-daily darunavir is marketed as Prezista in the European Union. If approved, the fixed-dose combination tablet will be marketed under a new brand name and will, for the first time, offer an option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.

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