Results Wire: US FDA Advisory Committee Supports Vertex’s Kalydeco (ivacaftor) for Cystic Fibrosis Patients With an R117H Mutation– OCT 21, 2014 (PADAC)

On Tuesday, October 21, 2014, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) supported, by a vote of 13-Yes to 2-No, the safety and efficacy of Vertex’s Kalydeco (ivacaftor) for cystic fibrosis patients aged 6 years and older with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

See the SAC Tracker Report