Results Wire: US FDA Advisory Committee Nearly Unanimously Supports Vertex’s Orkambi for Cystic Fibrosis – MAY 12, 2015 (PADAC)
On Tuesday, May 12, 2015, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) supported, by a vote of 12-Yes to 1-No, with no abstentions, the safety and efficacy of Orkambi (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.