Janssen submits NDA for single-tablet HIV regimen containing darunavir

Janssen announced today that it has submitted a new drug application to the FDA for a once-daily, darunavir-based HIV regimen for adults and children aged 12 years and older.

The single-tablet regimen contains 800 mg of darunavir, 150 mg of Tybost (cobicistat, Gilead Sciences), 200 mg of emtricitabine and 10 mg of Vemlidy (tenofovir alafenamide, Gilead Sciences; D/C/F/TAF), according to a company press release.

“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,” Richard Nettles, vice president of medical affairs at Janssen, said in the release. “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.”

The filing is based on data from two noninferiority, phase 3 trials — EMERALD and AMBER — in which D/C/F/TAF was associated with high rates of virologic suppression, the release said. The EMERALD trial included 763 virologically suppressed patients who switched to D/C/F/TAF and 378 patients who continued treatment on a boosted protease inhibitor plus emtricitabine and Viread (tenofovir disoproxil fumarate, Gilead Sciences; F/TDF). The AMBER trial included 362 treatment-naive patients who received D/C/F/TAF and 363 who received D/C with F/TDF.

According to 24-week data from the EMARLD trial, presented at the International AIDS Society conference in July, 96.3% in patients taking D/C/F/TAF and 95.5% in the control group experienced virologic suppression, with virologic failure occurring in 0.5% and 0.8% of patients, respectively. Additional data from EMERALD will be presented at IDWeek, held Oct. 4 to 8, and 48-week data from AMBER will be presented at the European AIDS Conference, held from Oct. 25 to 27.

According to Janssen, D/C/F/TAF is currently undergoing European regulatory review by the European Medicines Agency under the brand name Symtuza. Janssen and its affiliates hold rights to manufacture, register, distribute and commercialize D/C/F/TAF as a single-tablet regimen worldwide through a licensing agreement between Janssen and Gilead Sciences.

Reference:

Molina J-M, et al. Efficacy and safety of switching from boosted-protease inhibitor plus emtricitabine/tenofovir disoproxil fumarate regimens to the single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in virologically suppressed, HIV-1-infected adults through 24 weeks: EMERALD Study. Presented at: IAS Conference on HIV Science; July 23-26, 2017; Paris.

Disclosure: Nettles is an employee of Janssen.