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CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.
Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.
The FDA grants priority review to medicines that it determines to offer major advances in treatment or provide a treatment where no adequate therapy exists; standard review time is 10 months, but priority review reduces it to six, meaning the agency plans to finish its review by May 23. In Canada, standard review time is 18 months, and priority review reduces it to between six and nine.
“Data from phase-3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Vertex chief scientific officer and EVP global research and development. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”