European advisory committee backs Gilead's TAF for HBV
Seeking Alpha
Published Nov 11, 2016 08:21AM ET
European advisory committee backs Gilead's TAF for HBV
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Gilead Sciences' (NASDAQ:GILD) Vemlidy (tenofovir alafenamide, TAF) 25 mg for the treatment of adults and adolescents (at least 12 years old and 35 kg body weight) with chronic hepatitis B virus (HBV) infection. The data in the application supports the use of Vemlidy in treatment-naive and treatment-experienced adults and adolescents who are e antigen (HBeAg)-positive and HBeAg-negative.
- A final decision from the European Commission usually takes ~60 days.
- Vemlidy was OK'd in the U.S. yesterday for use in adults.
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