Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat

Janssen Submits Marketing AuthorisationJanssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat PR Newswire BEERSE, Belgium, October 15, 2013 Janssen-Cilag International NV (Janssen), today announced it 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, a protease inhibitor developed by Janssen, with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc. (Gilead) for use in combination with other human immunodeficiency virus (HIV-1) medicines. ®Once-daily darunavir is marketed as PREZISTA in the European Union. ®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 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, single tablet fixed-dose combination product of darunavir and Gilead's cobicistat.