Marketing application for HBV drug under review by EMA

The European Medicines Agency is currently reviewing Gilead Science’s marketing authorization application for tenofovir alafenamide for the treatment of adults with chronic hepatitis B virus infection, according to a press release from the manufacturer.

“Chronic hepatitis B infection is a major health concern in Europe, with 14 million people living with the disease and more than 1 million Europeans newly infected with the virus each year,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in the release. “The validation of this application represents the latest step in our continued efforts to advance the care of people living with progressive liver diseases like HBV.”

Tenofovir alafenamide (TAF, Gilead Sciences), a prodrug of tenofovir, was recently validated by the EMA and is supported by phase 3 clinical trial data that showed high efficacy similar to Viread (tenofovir disoproxil fumarate, Gilead Sciences) in treatment-naive and -experienced adults with hepatitis B e antigen (HBeAg)-negative and HBeAg-positive chronic HBV, according to the 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.

If authorized, Gilead Sciences will have marketing authorization in all 28 member states of the European Union, Norway and Iceland. Gilead Sciences submitted a new drug application to the FDA for tenofovir alafenamide for chronic HBV in January.

Disclosure: Bischofberger is employed by Gilead Sciences.