FDA advisory committee recommends approval of KALYDECO(R) (ivacaftor)
Vertex announced the FDA's Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO® (ivacaftor) in people with cystic fibrosis ages 6 and older who have the R117H mutation in the CFTR gene, which is the indication being reviewed by the FDA. October 21, 2014