FDA Advisory Committee Gives Cystic Fibrosis Drug Kalydeco (ivacaftor) Thumbs-Up for Patients Six And Up With R117H Mutation
Vertex Pharmaceuticals Incorporated announced Tuesday that the U.S. Food and Drug Administration’s Pulmonary Allergy Drugs Advisory Committee (PADAC) voted 13-2 to recommend approval of Kalydeco (ivacaftor) in people with cystic fibrosis (CF) ages six and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene,…