FDA Drug Review News
FDA Expected to Vote on New Hepatitis C Drug This Month
A New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) last fall for a novel combination hepatitis C medication manufactured by Gilead. The product, sofosbuvir/velpatasvir, is currently undergoing FDA review for the treatment of all 6 genotypes of chronic hepatitis C, including patients with compensated cirrhosis. For patients with decompensated cirrhosis, it is being evaluated for use in combination with ribavirin. The FDA is expected to make a decision regarding approval by June 28, 2016.
Sofosbuvir/velpatasvir is a once-daily, fixed-dose combination of the polymerase inhibitor sofosbuvir (Sovaldi®) and investigational NS5A inhibitor, velpatasvir. The combination product has received Breakthrough Therapy designation as it may provide a treatment advance over currently available therapies. In January of this year, sofosbuvir/velpatasvir was granted Priority Review by the FDA shortening the review time frame from the standard ten months to six months. Read more