European approval for hepatitis B drug Vemlidy

The European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25mg, 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 for US biotech major Gilead Sciences (Nasdaq: GILD) allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland.

"As the first new treatment for chronic hepatitis B to be approved in Europe in nearly a decade, this approval marks a step forward in the management of a progressive, life-threatening disease affecting 13 million Europeans," said Professor Pietro Lampertico, head of the Gastroenterology and Hepatology Division at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy, quoted by Gilead. "Treating a lifelong disease such as chronic hepatitis B can present challenges as patients age, and the improvements in bone and renal laboratory safety parameters demonstrated by TAF compared to TDF allow it to provide an important new option for patients," he noted.