Antiviral Drugs Advisory Committee recommends FDA to approve telaprevir for hepatitis C

April 09, 2016

"Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the Committee's unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA as it prepares to make its decision next month."

Safety and Tolerability Information for Telaprevir

The safety profile of telaprevir has been well characterized. Data from more than 40 clinical studies across a broad group of nearly 4,000 people were included in the new drug application. The side effects observed with telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common side effects, regardless of treatment arm, were fatigue, pruritus (itchiness), nausea, headache, rash, anemia, flu-like symptoms, insomnia and diarrhea with the majority being mild to moderate.

Rash and anemia occurred more frequently among those treated with telaprevir-based combination therapy. In Phase 3 studies, discontinuation of all medicines due to either rash or anemia during the telaprevir/placebo treatment phase was approximately 1 percent for rash and 1 percent for anemia. Rash was primarily characterized as eczema-like, manageable and resolved following discontinuation of telaprevir. More than 90 percent of rash was mild to moderate and investigators in the studies primarily used topical corticosteroids and/or antihistamines to treat rash. Anemia was primarily managed by reducing the dose of ribavirin.

Source: Vertex Pharmaceuticals Incorporated