EMA validates MAA for tenofovir alafenamide (as fumarate) (TAF) as a treatment for Hepatitis B- Gilead
Gilead Sciences, Inc. announced that the company�s Marketing Authorization Application (MAA) for tenofovir alafenamide (as fumarate) (TAF) 25 mg � 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 (EMA).
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead�s Viread 245 mg 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.
Comment: Gilead aims to switch patients to the new product, tenofovir alafenamide, ahead of loss of patent protection for Viread in hepatitis B. The drug was filed at the FDA in January 2016.
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