FDA Approval of Vertex’s Incivek Kicks Off Battle for Hepatitis C Market

The FDA has approved Vertex’s Incivek in combination with peginterferon alfa and ribavirin to treat adults with chronic hepatitis C and liver problems who are either treatment naïve or did not respond well to prior therapies. The Monday approval is based on three Phase III studies that showed patients receiving Incivek (telaprevir) combination treatment achieved higher rates of sustained viral response (SVR) than those receiving standard of care (pegylated interferon and ribavirin) alone. Vertex says Incivek will be available to patients this week. The company has 200 field-based employees across the U.S., including a 115-person sales team, readied to introduce telaprevir.
Drug Industry Daily