Janssen submits new drug application to FDA for HIV-1 treatment

Janssen Research & Development, LLC has announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF), a complete, once daily regimen being investigated for the treatment of human immunodeficiency virus type 1 (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 a high genetic barrier to darunavir resistance 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 studies:

EMERALD, a 48-week, non-inferiority study evaluating the efficacy and safety of switching to D/C/F/TAF (n=763) versus continuing on a boosted protease inhibitor (PI) plus F/TDF regimen (n=378).

AMBER, a 48-week non-inferiority study evaluating the efficacy and safety of D/C/F/TAF (n=362) versus control of a DRV/C+F/TDF (n=363) in treatment-naïve patients.

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.

"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.