FDA approves Gilead’s hepatitis C drug Epclusa

SILVER SPRING, Md. — The Food and Drug Administration has approved Gilead Sciences’ Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the company announced earlier this week. Epclusa is a single tablet treatment for adults with genotype 1-6 chronic hepatitis and for patients with hepatitis C genotype 2 and 4 without the need for ribavirin. The drug for 12 weeks was approved for use in patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin. 

 

“Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

 

Epclusa received Priority Review and Breakthrough Therapy designations from the FDA.