Janssen files NDA to U.S. FDA for the first Darunavir-based tablet for HIV-1

Janssen has submitted a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) for darunavir several doses, for treating HIV-1.

The applied doses are 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF), for HIV-1 infection in adults and pediatric patients aged 12 years and older. If approved, D/C/F/TAF will be the only complete regimen to deliver the potential adherence advantages of a single tablet regimen (STR) with the high genetic barrier to resistance of darunavir and demonstrated safety profile of TAF. Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.

The filing is based on results from two pivotal Phase 3 48 week studies, EMERALD, and AMBER.

To date, Phase 3 D/C/F/TAF trials demonstrate high rates of virologic suppression and no treatment-emergent DRV or TAF resistance among both treatment-naïve adult patients and virologically suppressed adult patients who switched regimens. EMERALD 48-week data will be presented at ID Week 2017, October 4-8 in San Diego, California, and AMBER 48-week data will be presented at the European AIDS Conference, October 25-27 in Milan, Italy.

“This filing marks an important milestone in continuing to address the needs of individuals living with HIV who struggle with adherence and the associated risk of developing medication resistance,” said Richard Nettles, Vice President, Medical Affairs, Janssen. “If approved, this treatment will enable us to expand our promising portfolio of products for those living with HIV to include a medicine that for the first time brings together darunavir’s high genetic barrier to resistance with the safety profile of tenofovir
alafenamide, in a once daily, single-pill dosing regimen.”

As part of a longstanding commitment to the research and development of treatments for HIV, Janssen has brought several important medicines to market to help improve the efficacy and tolerability of treatment. Today’s submission builds on this legacy and exemplifies Janssen’s ongoing dedication to those living with HIV.

To remind, on December 23, 2014, Janssen and Gilead Sciences Inc. amended a licensing agreement for the development and commercialization of a once-daily STR combination of darunavir and Gilead’s TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialization of this STR worldwide.