The US FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee (PADAC) for Tuesday, May 12, 2015. The Committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, 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 FDA Announcement