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CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.
Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.
If the FDA grants Vertex's request for priority review, it will reduce the amount of time needed to review the application from 10 months to six months.
"Kalydeco represents a completely new approach to the treatment of CF by targeting the underlying cause of the disease," Vertex president, chairman and CEO Matthew Emmens said. "This is our second new drug application in less than a year, which is a significant achievement and underscores our commitment to developing new medicines for people with serious diseases."
The FDA approved Vertex's hepatitis C drug Incivek (telaprevir) in May.