Gilead Submits NDA for Hepatitis B DrugBy
Gilead Sciences, Inc. has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread (tenofovir disoproxil fumarate, TDF), as well as improvements in surrogate laboratory markers of renal and bone safety as compared to Viread, according to Gilead.
Gilead plans to submit a regulatory application for TAF in the European Union in the first quarter of 2016.
Source: Gilead Sciences