Janssen Announces Submission of Marketing App in Europe for Darunavir-Based Single Tablet Regimen (JNJ)

September 12, 2016 7:32 AM EDT

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Janssen-Cilag International NV (Janssen) announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA), seeking approval for a new once-daily darunavir-based single tablet regimen (STR). If approved, this tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC), 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 combine the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg) and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) and tenofovir alafenamide (TAF 10 mg), in one single tablet.

Treatment regimens that combine DRV/COBI (REZOLSTA®, Janssen-Cilag International NV) and F/TAF (Gilead Sciences International Ltd) are currently approved1,2 for the maintenance treatment of HIV. The darunavir STR option is a significant evolution of this approach, combining both treatments in a single, convenient tablet.

“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,” said Lawrence M. Blatt, Ph.D., global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma, Inc. “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.”

On 29 December 2014, Janssen announced a license agreement with Gilead for the development and commercialisation of a once daily STR combination of darunavir and Gilead’s cobicistat, emtricitabine and tenofovir alafenamide. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialisation of this STR worldwide. Gilead retains sole rights for the manufacturing, development and commercialisation of cobicistat, emtricitabine and tenofovir alafenamide as stand-alone products, and for use in combination with other agents.

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