Gilead files for US approval of new TAF hepatitis B drug

13 January 2016

US biotech major Gilead Sciences (Nasdaq: GILD) has submitted a New Drug Application to the US Food and Drug Administration for tenofovir alafenamide (TAF), 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.

"Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy," commented Norbert Bischofberger, the firm’s executive vice president, R&D, and chief scientific officer, adding: "Given its lower dose, efficacy and safety profile, TAF has the potential to offer patients an improved treatment option that may advance their long-term care of chronic HBV."

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