EMA validates Gilead's marketing application for TAF for chronic hepatitis B

US biotech giant Gilead Sciences (Nasdaq: GILD) revealed today that the Marketing Authorization Application tenofovir alafenamide (as fumarate; TAF) 25mg – an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection – has been fully validated and is now under assessment by the European Medicines Agency.

TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead’s Viread 245mg of tenofovir disoproxil (as fumarate; TDF) at one-tenth of the dose. TAF also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.

“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,” said Norbert Bischofberger, executive vice president, R&D, and chief scientific officer, Gilead Sciences, adding: “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.”