EU approves hepatitis B therapy Vemlidy

Gilead Sciences, Inc. on January 11  announced that the European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg). The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland. It is estimated that 13 million Europeans are affected by this life-threatening disease.  

Vemlidy was approved by the U.S. Food and Drug Administration on November 10, 2016 for the treatment of chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labour and Welfare on December 19, 2016.

“TAF reflects Gilead’s ongoing commitment to improve and simplify care for people with chronic infectious diseases, including hepatitis B, while we continue our research efforts for curative treatments,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.