Janssen is seeking FDA approval for its once-daily darunavir-based regimen for HIV.
Janssen recently submitted a New Drug Application for its 4-in-1 single tablet regimen to treat adult patients with HIV and pediatric patients aged 12 years and older.
The investigational once daily regimen is composed of darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/alafenamide 10 mg (D/C/F/TAF), according to a press release. If approved, it would be the only complete regimen to have the adherence advantages of a single tablet regimen with a high genetic barrier to darunavir treatment resistance and a demonstrated safety profile of TAF, according to the release.
The application submission is based on data from the pivotal phase 3 studies EMERALD and AMBER. The 48-week, non-inferiority EMERALD study was designed to evaluate the safety and efficacy of switching to D/C/F/TAF compared with remaining on a boosted protease inhibitor plus F/TDF regimen.
The AMBER trial was also a 48-week non-inferiority study evaluating the safety and efficacy of D/C/F/TAF compared with control of a DRV/C+F/TDF in treatment-naïve patients.
“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.”
Thus far, trials examining D/C/F/TAF demonstrate high rates of virologic suppression and no treatment-emergent DRV or TAF resistance in treatment-naïve adults with HIV and virologically suppressed adults who switched regimens.
Data from the EMERALD trial will be presented at ID Week 2017, October 4-8 in San Diego, California, and data from the AMBER trial will be presented at the European AIDS Conference, October 25-27 in Milan, Italy.