The European Commission approved Gilead Science’s marketing authorization application for Epclusa for the treatment of all chronic hepatitis C genotypes, according to a press release from the manufacturer.
Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is an investigational, pangenotypic, once-daily tablet containing 400 mg sofosbuvir and 100 mg velpatasvir. It has been approved as treatment for 12 weeks for use in patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin for patients with decompensated cirrhosis.
The authorization allows for the marketing of sofosbuvir/velpatasvir in all 28 countries of the European Union and comes after The European Committee for Medicinal Products for Human Use granted a positive opinion on the regimen in May after an accelerated review procedure.
“Built on the foundation of sofosbuvir, [sofosbuvir/velpatasvir] offers a highly effective and tolerable choice which is protease inhibitor-free and ribavirin-free for the majority of patients. For the first time we have a once-daily, single-tablet treatment option which works across all genotypes, including genotype 3, which is often the least responsive to treatment,” Stefan Zeuzem, MD, chief of the department of medicine at J.W. Goethe University Hospital, Frankfurt, Germany, said in the release. “This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe.” Read more…