Sep 12, 2016
Janssen-Cilag International NV (Janssen) has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA), which seeks approval for a new once-daily darunavir-based single tablet regimen (STR). This tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC) if approved, indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg).
This new treatment would be the combination of the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg), tenofovir alafenamide (TAF 10 mg), and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) in one single tablet.
Lawrence M. Blatt, Ph.D., global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma, Inc., said: “Darunavir is an extensively used HIV protease inhibitor in the European Union. We are excited to take this important step in our efforts to offer simpler solutions for people living with HIV. Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. Eliminating the need for separate tablets will not only be convenient for people living with HIV but is likely to lead to improved treatment adherence.”