Tenofovir alafenamide filed with FDA for hepatitis B- Gilead

Gilead Sciences has submitted a New Drug Application to the FDA for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection. Gilead plans to submit a regulatory application for TAF in the European Union in the first quarter of 2016.

The NDA for TAF is supported by 48-week data from two Phase III studies, which met their primary objective of non-inferiority in efficacy compared to Gilead’s Viread among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, changes in renal and bone laboratory safety parameters favoured the TAF regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving Viread. Additionally, the overall median change in serum creatinine from baseline to week 48 favoured TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.