Gilead submits NDA for tenofovir alafenamide for chronic HBV

Gilead Sciences, Inc. announced it has submitted a new drug application to the FDA for tenofovir alafenamide for the treatment of chronic hepatitis B virus infection.

The application for tenofovir alafenamide (TAF; Gilead Sciences), a novel, targeted prodrug of tenofovir, is supported by data from two phase 3 clinical trials that investigated the safety and efficacy of TAF compared with Viread (tenofovir disoproxil fumarate [TDF], Gilead Sciences) in treatment-naive and -experienced adults with hepatitis B e antigen (HBeAg)-negative and HBeAg-positive chronic HBV, according to a press release.

In both clinical trials, patients who received TAF experienced a smaller mean percentage decrease from baseline in hip and spine bone mineral density at 48 weeks compared with patients who underwent treatment with TDF. In addition, an overall median change in serum creatinine from baseline to 48 weeks showed favorable results for TAF compared with TDF.

“Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy,” Norbert Bischofberger, PhD, executive vice president, Research and Development and chief scientific officer at Gilead Sciences, said in the release. “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.”

A regulatory application for TAF in the European Union will be submitted by Gilead Sciences in the first quarter of 2016, according to the release.

Disclosure: Bischofberger is employed by Gilead Sciences.