FDA approves Incivek as hepatitis C treatment

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.

“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” FDA Office of Antimicrobial Products director Edward Cox said. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”

The announcement comes a little more than a week after the FDA approved Merck’s hepatitis C drug Victrelis (boceprevir).