Janssen-Cilag International NV (Janssen), has submitted a Marketing Authorisation Application (MAA) 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 (FDC) 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. Under the terms of the agreement, Janssen and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the darunavir and cobicistat fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

"Over the last six years, Janssen has launched three therapies for people living with HIV and is committed to further evaluating HIV therapies for a broad range of patients. We are therefore excited to be applying for marketing authorization for a single tablet combination product which includes darunavir, the leading protease inhibitor worldwide, with an alternative boosting agent," said, Johan van Hoof, therapeutic area head, Infectious Diseases and Vaccines, Janssen. "This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease.  The ultimate goal is to help all patients achieve an undetectable viral load and a better quality of life."

Darunavir, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of three years and at least 15 kg body weight.

Since its initial approval in 2007, darunavir has also been indicated for use in HIV-1 infected treatment-naïve and treatment-experienced adult patients, including those who have been highly pre-treated, in combination with ritonavir and other ARTs. For treatment-experienced adult patients, the licensed dosing for darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily with food or 800 mg taken with 100 mg ritonavir once daily with food for patients with no DRV Resistance Associated Mutations (RAMs) and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count = 100 cells x 106/L. For treatment-naive adult patients, the licensed dosing for darunavir is 800 mg taken with 100 mg ritonavir once daily with food.

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