Reuters Health Information (2011-01-20): Vertex Pharma's hepatitis C drug gets priority review
Vertex Pharma's hepatitis C drug gets priority review
Last Updated: 2011-01-20 10:57:27 -0400 (Reuters Health)
by Vidya L Nathan
BANGALORE (Reuters) - Vertex Pharmaceuticals Inc said its experimental treatment for hepatitis C got priority review status from health regulators in the United States and Canada.
Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.
Priority review status from the FDA reduces the review period by 4 month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to 6 to 9 months, compared to a review period of 18 months or more.
Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson, and Mitsubishi Tanabe Pharma.
Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.