The European Commission has granted Gilead’s Vemlidy European marketing authorisation, making it the first new hepatitis B virus (HBV) treatment to receive EU approval in nearly a decade.
Confirming the CHMP’s November approval recommendation, the EC gave Vemlidy the nod for the treatment of chronic HBV infection in adults and adolescents in all 28 EU member states, plus Norway and Iceland.
It has already received US FDA authorisation for use in adults with chronic HBV infection and compensated liver disease, and also got the green light from the Japanese Ministry of Health, Labour and Welfare at the end of 2016.
Vemlidy (tenofovir alafenamide, TAF) is a once-daily oral treatment, and produces a similar antiviral efficacy to its predecessor Viread (tenofovir disoproxil fumarate, TDF) but at only 10% of the dosage. With less tenofovir in the bloodstream, TAF therapy sees improved renal and bone safety outcomes compared to TDF treatment.
Dr Norbert Bischofberger, chief scientific officer and executive vice president of R&D at Gilead, said: “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.
“We look forward to making TAF available as quickly as possible throughout the European Union.”
HBV is the second-most common cause of cancer and the Hepatitis B Foundation says 240 million people are chronically infected with HBV globally, causing 680,000 deaths every year.
In Europe, a WHO report from 2016 showed that 13 million people are currently living with chronic HBV, with an average of one million people infected annually.