Posted by Michael Wonder on 05 Feb 2016
Vertex receives complete response letter from U.S. FDA for use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 2 and older with one of 23 residual function mutations
5 February 2016 - The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.
For more details, go to: http://investors.vrtx.com/releases.cfm?hdr02=press
