Janssen Seeks EMA Approval for Once-Daily Dosing of HIV Therapy

Janssen-Cilag International, part of Johnson & Johnson, has submitted a marketing authorization application to the European Medicines Agency seeking approval for a new once-daily darunavir-based single tablet regimen (STR) for human immunodeficiency virus (HIV) treatment. If approved, this tablet would be indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kilograms. Darunavir is the active ingredient in Janssen’s HIV medicine, Prezista.

The 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.

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

Source: Johnson & Johnson

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