The European Union has granted marketing authorization for Vemlidy (tenofovir alafenamide, or TAF), Gilead Sciences’ pioneering treatment for chronic hepatitis B virus (HBV) infection in adults and teens with compensated liver disease (early cirrhosis).
Vemlidy will be soon available in the 28 countries of the EU, as well as in Norway and Iceland. The 25 mg, once-daily tablets are indicated for people ages 12 and older who weigh at least 77 pounds.
Vemlidy was approved by the U.S. FDA in November 2016, and by the Japanese Ministry of Health in December.
“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,” Pietro Lampertico, a professor at the University of Milan in Italy, said in a press release.
Vemlidy is an innovative, targeted prodrug of tenofovir that has proven antiviral effectiveness levels similar to those of Viread (tenofovir disoproxil fumarate, or TDF) 245 mg, but at one-tenth the dose, lessening the risk of side effects. Viread is also a Gilead product.
“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,” Lampertico added.
Clinical results showed that Vemlidy’s greater plasma stability can more effectively deliver tenofovir to hepatocytes (cells of the liver), which are associated with improved results in certain bone and kidney parameters, as well as higher rates of normalization of blood serum alanine aminotransferase (ALT) levels, a marker of liver damage.
The approval of Vemlidy was supported by two international Phase 3 studies in 1,298 adult chronic HBV patients. The two studies enrolled patients who had been previously treated with other drugs and patients who had never been treated.
The first study (NCT01940341) randomized 425 patients with HBV who tested negative for hepatitis B e antigen (HBeAg), and the second study (NCT01940471) randomized 873 patients with HBV who tested positive for HBeAg.
Both studies compared Vemlidy to Viread for 48 weeks and both studies achieved their primary endpoint – proving Vemlidy was not inferior to Viread.
The most common adverse events reported for Vemlidy included diarrhea, nausea, abdominal pain, and headaches.
“TAF [Vemlidy] 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 of research and development and chief scientific officer at Gilead. “We look forward to making TAF available as quickly as possible throughout the European Union.”