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news.Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg to treat adults with chronic hepatitis B virus (HBV) infection.
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TAF is a novel, once-daily, targeted prodrug of tenofovir that showed high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF).
The NDA submission is based on a 48-week data from two phase 3 trials which demonstrated that TAF is non-inferior in efficacy to Viread in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV.
The TAF regimen also showed 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.
Gilead Sciences executive vice president of research and development and chief scientific officer Norbert Bischofberger said: "Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy.
"Given its lower dose, efficacy and safety profile, TAF has the potential to offer patients an improved treatment option that may advance their long-term care of chronic HBV."
The company intends to submit a regulatory application for TAF in the European Union in the first quarter of this year.