FDA to Review TAF NDA for Chronic HBV Infection
Gilead announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25mg for the treatment of adults with chronic hepatitis B virus (HBV) infection.
The NDA submission is based on a 48-week data from two Phase 3 studies which showed that TAF is non-inferior in efficacy to Gilead's Viread in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. The TAF regimen also demonstrated a more favorable safety profile, with significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density, and less overall median change in serum creatinine from baseline at Week 48 compared to Viread.
TAF, a nucleotide reverse transcriptase inhibitor (NRTI), is a novel, once-daily, targeted prodrug of tenofovir.
For more information call (800) 445-3235 or visit Gilead.com.