Janssen seeks European approval of HIV combination drug

Janssen has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product.

The product contains darunavir, a protease inhibitor developed by Janssen, and cobicistat, a boosting agent developed by Gilead Scinces, and 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 3 years and at least 15 kg body weight.

"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. 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."

Johan van Hoof, Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen.

Darunavir on its own is marketed as Prezista in the European Union. If this new combination product is approved, it will be marketed under a new brand name.

Janssen and Gilead entered into a licensing agreement back in June 2011 for the development and commercialization of a once-daily, single tablet fixed-dose combination product of darunavir and cobicistat.