Gilead Sciences’ new hepatitis B therapy accepted for EU regulatory review

Gilead Sciences has had a marketing authorisation application for its new hepatitis B therapy tenofovir alafenamide accepted by the European Medicines Agency.

The investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection is to be assessed by the European regulator based on data from two phase III clinical trials.

In these studies, the new therapy offered antiviral efficacy comparable to Gilead's established therapy Viread at one-tenth of the dose. It also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to Viread.

The company is also currently seeking US regulatory approval for the drug, having submitted a new drug application to the Food and Drug Administration last month.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "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."

The condition is recognised as a chronic disease that requires prolonged therapy, creating demand for new treatment options.