FDA advisors back Vertex HCV drug

An advisory committee to the US Food and Drug Administration (FDA) has unanimously backed Vertex Pharmaceuticals' investigational new therapy for hepatitis C.

The Antiviral Drugs Advisory Committee voted 18-to-0 to recommend FDA approval of telaprevir for the treatment of genotype 1 chronic hepatitis C, the most common and hardest to treat form of the disease, in patients not treated previously as well as those who were treated previously but not cured.

The FDA is not obligated to follow the recommendations of its advisory committees, but frequently does so. Vertex said it expects a decision on telaprevir from the federal agency by May 23.

The advisory committee made its recommendation after reviewing 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.

In addition, telaprevir-based combination therapy often takes far less time than currently available therapies, according to Vertex. In the phase III studies, two-thirds of people not treated previously were able to complete their treatment within six months.

Vertex is developing the oral therapy 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.

The Antiviral Drugs Advisory Committee's recommendation on the Vertex drug comes after the committee's unanimous positive recommendation on a similar Merck drug, an investigational hepatitis C therapy known as Victrelis (boceprevir). The agency is aiming to make a decision on Merck's marketing application by mid-May.