EATG » Janssen submits new drug application to FDA for the first darunavir-based single tablet regimen for the treatment of HIV-1

Janssen submits new drug application to FDA for the first darunavir-based single tablet regimen for the treatment of HIV-1

Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir alafenamide in a once daily pill

TITUSVILLE, N.J., Sept. 25, 2017 — Janssen Research & Development, LLC today 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 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 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. 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.

Notes to editors

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.

About Janssen

At Janssen, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.

About the AMBER clinical trial

The Phase 3 AMBER study is a randomized, active-controlled, double-blind, international, multi-center, parallel-group, non-inferiority study to evaluate efficacy and safety of D/C/F/TAF versus D/C with F/TDF in antiretroviral treatment-naïve HIV- 1 infected adults. The primary endpoint of the trial was the proportion of virologic responders, defined as HIV-1 RNA <50 copies /mL at Week 48 FDA snapshot approach, between arms, with a maximum allowable difference of 10%. 725 patients were randomized and treated as follows: 362 D/C/F/TAF; 363 control.

For more information on the clinical trials please visit: www.clinicaltrials.gov

About the EMERALD clinical trial 

The Phase 3 EMERALD study is a randomized (2:1), open-label, international, multi-center, parallel-group, non-inferiority, 48-week study evaluating the efficacy and safety of switching to D/C/F/TAF versus continuing with a boosted PI plus F/TDF (control) in adult HIV-1 infected patients who are virologically suppressed (VL<50c/mL) for ≥2 months and had no more than one a viral load VL≥50c/mL over the last 12 months. The FDA-stipulated primary endpoint of the trial is the proportion of patients with cumulative virologic rebound (confirmed VL≥50c/mL or premature discontinuations with last VL≥50c/mL) through Week 48 (non-inferiority margin=4%). 1,141 patients were randomized and treated as follows: D/C/F/TAF (n=763); control (n=378).

For more information on the clinical trials please visit: www.clinicaltrials.gov

Source:
PRNewswire
News categories: HIV treatment, EMA/FDA