Janssen files darunavir/cobicistat HIV combo in the EU
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir, from Janssen, with cobicistat, from Gilead Sciences, for use in combination with other Human Immunodeficiency Virus (HIV-1) medicines. 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.
Janssen announced a license agreement with Gilead for the development and commercialization of this once-daily, single tablet fixed-dose combination product in June 2011. Once-daily darunavir is marketed as Prezista in the European Union and cobicistat is marketed by Gilead Sciences as Tybost.
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