Single tablet emtricitabine + tenofovir alafenamide + rilpivirine submitted to FDA for HIV/AIDS-Gilead Sciences/Janssen

Gilead Sciences has submitted a New Drug Application to the FDA for an investigational, once-daily single tablet regimen that combines Gilead�s emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) from Janssen Sciences Ireland UC, for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. Gilead plans to submit a regulatory application for R/F/TAF in the European Union in the third quarter of 2015.

A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) NDA. Under the Prescription Drug User Fee Act (PDUFA), the anticipated target action date for the R/F/TAF NDA is six months after the FDA�s acceptance of the filing. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-na�ve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. The NDA is supported by a bioequivalence study demonstrating that R/F/TAF achieved the same drug levels of emtricitabine and TAF in the blood as E/C/F/TAF (10 mg TAF dosage - see Comment below) and the same drug levels of rilpivirine as a 25 mg dose of rilpivirine (Edurant) alone. The safety and efficacy of TAF is supported by a number of clinical studies in a range of patients with HIV, including treatment-na�ve adults and adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. In studies, TAF-based treatment (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to TDF-based therapy (administered as E/C/F/TDF or Stribild).

Comment: In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review. In November 2014, Gilead filed an NDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Gilead filed another NDA in April 2015 for two doses of an investigational, fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for use in combination with other HIV antiretroviral agents. Under the PDUFA, the FDA has set a target action date of November 5, 2015, for E/C/F/TAF and April 7, 2016, for F/TAF. Marketing Authorization Applications in the European Union were fully validated on December 23, 2014, and May 28, 2015, for E/C/F/TAF and F/TAF respectively.