Briefing Summary: US FDA Posts Advisory Committee Materials for Vertex’s Kalydeco (ivacaftor) for Cystic Fibrosis – OCT 21, 2014 (PADAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, October 21, 2014 Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting. The committee will discuss supplemental new drug application (sNDA) 203188, Kalydeco (ivacaftor) oral tablets, submitted by Vertex Pharmaceuticals Inc. (Vertex), for the treatment of cystic fibrosis (CF) in adult patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.