Case Study : USFDA approval of Vosevi for Hepatitis C

The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.

Features:

• Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV.
• Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.
• The safety and efficacy of Vosevi was evaluated in two Phase 3 clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis.

The FDA granted this application Priority Review and Breakthrough Therapy designations.

The FDA granted approval of Vosevi to Gilead Sciences Inc.