Briefing Summary: US FDA Posts Advisory Committee Materials for Vertex’s Ivacaftor/Lumacaftor Combination for Cystic Fibrosis – MAY 12, 2015 (PADAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, May 12, 2015 Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting. The Committee will 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.

See the SAC Tracker report