The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals' new therapy for hepatitis C, a tablet known as Incivek (telaprevir). Vertex said the drug will be available in pharmacies this week and that the company will support the launch with 200 field-based employees across the US, including a 115-person sales team.
The FDA approved Incivek for the treatment of genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis, in patients not treated previously as well as those who were treated previously but not cured. Genotype 1 is the most common and hardest to treat form of the disease.
The approval was based on phase III studies in which telaprevir was given for 12 weeks in combination with pegylated-interferon and ribavirin (P/R) followed by P/R alone for a total of 24 weeks or 48 weeks of treatment.
Study subjects who received telaprevir-based combination therapy achieved significantly higher rates of sustained viral response compared to treatment with 48 weeks of P/R alone, regardless of whether or not they had received previous treatment. In the subgroup of patients who had received no previous treatment, 79 per cent achieved a viral cure with telaprevir-based combination therapy compared to 46 per cent who achieved a viral cure with P/R alone.
The FDA's decision on the drug follows a unanimous recommendation for approval made by the Antiviral Drugs Advisory Committee earlier in May.
The decision on Incivek comes shortly after the May 13 US approval of Merck's similar HCV drug Victrelis (boceprevir).
"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," said Edward Cox, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward."
Vertex developed Incivek in partnership with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has marketing rights in North America, while Tibotec has rights in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialise telaprevir in Japan and certain Far East countries.