Janssen-Cilag International NV (Janssen) 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 (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 2011, Janssen and Gilead entered into a license agreement for the development and commercialisation of a once-daily, single tablet fixed-dose combination product of darunavir and Gilead’s cobicistat. Janssen and its affiliates are responsible for formulation, manufacturing, registration, distribution and commercialisation of the darunavir and cobicistat fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development and commercialisation of cobicistat as a stand-alone product and in combination with other agents.
EP News Bureau – Mumbai
- Advertisement -
