FDA approves Vertex for phase III telaprevir study

CAMBRIDGE, Mass. Vertex Pharmaceuticals has received approval from the Food and Drug Administration to conduct phase III studies of its hepatitis C drug telaprevir, according to published reports.

The company will conduct two phase III trials to satisfy FDA regulations. The first study will enroll 1,050 patients with newly diagnosed hepatitis C and will evaluate two different telaprevir regimens, each totaling 24 weeks in length. The patients will be compared to patients treated with the current standard of care for 48 weeks.

The second, smaller study will test a telaprevir-containing regimen that lasts 48 weeks, again compared to a 48-week standard of care. This study will enroll between 400 and 500 newly diagnosed hepatitis C patients.

Both studies will run concurrently, with enrollment forecast to be completed by the end of the year. Vertex said it expects results from both studies should be ready for release in the middle of 2010. If positive, Vertex could seek FDA approval of telaprevir by the end of 2010, with an approval decision likely in mid-2011.

Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes the virus uses to copy itself. This “direct antiviral” approach differs from current hepatitis C drugs, which boost the immune system’s ability to tamp down and eliminate the virus.