Background Analysis: US FDA Advisory Committee to Review Vertex’s Ivacaftor/Lumacaftor Combination for Cystic Fibrosis – MAY 12, 2015 (PADAC)
The US FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee (PADAC) for Tuesday, May 12, 2015 to discuss new drug application (NDA) 206038 for ivacaftor/lumacaftor combination tablets, submitted by Vertex Pharmaceuticals (Vertex), proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.