Janssen submits new HIV therapy for EU approval

Janssen has filed for European regulatory approval of a once-daily single-tablet antiretroviral combination therapy for HIV.

The marketing authorisation application submitted to the European Medicines Agency pertains to a combination of Janssen's protease inhibitor darunavir and Gilead Sciences' pharmacokinetic enhancer cobicistat.

Should this new product be approved, it would offer an option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir.

Currently, darunavir is marketed under the brand name Prezista in Europe and is always taken with and at the same time as another pharmacokinetic enhancer called ritonavir.

Johan van Hoof, therapeutic area head of infectious diseases and vaccines at Janssen, said: "This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease."

Earlier this month, the company announced that its new drug Simponi has been approved as a therapy for adult patients with moderate to severely active ulcerative colitis.