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Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Tenofovir Alafenamide (TAF) for Patients with Chronic Hepatitis B Infection

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Additional Relevant Details Gilead has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.

The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy (HBV DNA < 29 IU/mL at Week 48) compared to TDF among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection. Both studies enrolled patients from a number of clinical sites in Japan. Patients randomized to the TAF arms showed a statistically significant increase in serum alanine aminotransferase normalization relative to the TDF arms when using the American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment arms. Overall, patients receiving TAF experienced a significantly smaller percentage decrease from baseline in hip and spine bone mineral density at Week 48 compared to patients receiving Viread. Additionally, the overall change in serum creatinine from baseline to Week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.
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Occurred on:
Mar 31, 2016
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Related Keywords Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, Viread