Gilead’s Vemlidy to be approved in Europe

Gilead announced that the European Commission has granted marketing authorization for Vemlidy® (tenofovir alafenamide) 25 mg in the 28 countries of the European Union, Norway and Iceland. Vemlidy is 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 of at least 35 kg). It is the first new therapy for chronic hepatitis B to be approved in Europe in nearly a decade. The condition affects 13 million people in Europe. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Viread® (tenofovir disoproxil fumarate, TDF), but at one-tenth the dose. This is due to Vemlidy having greater plasma stability, hence it efficiently delivers tenofovir to hepatocytes. Vemlidy was already approved in the US in November 2016 for the treatment of chronic HBV infection in adults with compensated liver disease. One month later, it was approved in Japan as well. (Source Gilead)