Janssen submits marketing authorisation application for darunavir-based single tablet regimen for treatment of HIV-1 to European Medicines Agency

12 September 2016 - Janssen today announced the submission of a Marketing Authorisation Application to the 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.

Read Janssen press release

Michael Wonder

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Michael Wonder