NDA for First Darunavir-Based Single-Tab HIV Regimen Submitted
The NDA submission included data from two Phase 3 trials of nearly 2,000 patients
Janssen announced the submission of a New Drug Application (NDA) for darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF) for the treatment of HIV-1 infection in patients aged ≥12 years. D/C/F/TAF will be the first darunavir-based, single-tablet HIV treatment, if approved.
The NDA submission included data from two Phase 3 clinical trials, EMERALD and AMBER. EMERALD is a randomized, open-label, multi-center, parallel group, non-inferiority study (n=1,141) that examined the safety and efficacy of switching to D/C/F/TAF vs. continuing on a boosted protease inhibitor (PI) with F/TDF in adults who are virologically suppressed (viral load <50 copies/mL) for ≥2 months with no more than 1 viral load ≥50 copies/mL over the last 12 months. The primary endpoint was the proportion of patients with cumulative virologic rebound (confirmed viral load ≥50 copies/mL or premature discontinuations last viral load ≥50 copes/mL) through Week 48.
AMBER is an active-controlled, double-blind, multicenter, parallel-group, non-inferiority study (n=725) that evaluated the safety and efficacy of D/C/F/TAF vs. DRV/C + F/TDF (control) in treatment-naive patients. The primary endpoint was the proportion of virologic responders (defined as HIV-1 RNA <50 copies/mL at Week 48).
Both studies have demonstrated high rates of virologic suppression with no treatment-emergent DRV or TAF resistance among treatment-naive adults and virologically suppressed adults who switched treatment regimens. The full 48-week data from EMERALD will be presented at ID week 2017 and the 48-week data from AMBER will be presented at the European AIDS Conference.
For more information call (800) 526-7736 or visit Janssen.com.