Janssen Announces Submission of Marketing App in Europe for Darunavir-Based Single Tablet Regimen (JNJ)
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Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency
September 12, 2016 7:30 AM EDTBEERSE, Belgium--(BUSINESS WIRE)-- Janssen-Cilag International NV (Janssen) today 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,... More
