- Gilead Sciences (NASDAQ:GILD) submits a New Drug Application (NDA) to the FDA seeking approval for a once-daily single tablet regimen for the treatment of patients at least 12 years old with HIV-1 infection. The drug combines Gilead's emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with Janssen Sciences Ireland's (NYSE:JNJ) rilpivirine (Edurant) 25 mg (R/F/TAF).
- The submission is Gilead's third TAF-related filing in the past 12 months. In November 2014 it filed an NDA for a once-daily single tablet E/C/F/TAF (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg). In April of this year, it filed another NDA for two doses of a fixed-dose combination of F/TAF (emtricitabine 200 mg/tenofovir 10 mg/20 mg). The PDUFA dates for E/C/F/TAF and F/TAF are November 5, 2015 and April 7, 2016, respectively. Gilead's Marketing Authorization Applications (MAAs) for both are currently under review in Europe.