Janssen-Cilag (Janssen) has submitted a marketing authorization application to the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet of HIV-1 medicine darunavir with cobicistat.
Developed by Janssen, darunavir is a protease inhibitor, while cobicistat a pharmacokinetic enhancer or boosting agent is developed by Gilead Sciences (Gilead).
In the EU, darunavir is marketed as PREZISTA and is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines.
If the drug gets EMA approval, it will be marketed under a new brand name and will, for the first time, provide an option that reduces the need to take a boosting agent in a separate tablet with once-daily darunavir.
The move follows a license agreement signed in June 2011 by both the companies to develop and commercialize a once-daily, single tablet fixed-dose combination product of darunavir and cobicistat.
Under the deal, Janssen and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the darunavir and cobicistat fixed-dose combination across the world.
The deal will see Gilead retain sole rights for the manufacturing, development and commercialization of cobicistat as a stand-alone product as well as for use in combination with other agents.
