ARTICLE | Politics & Policy

FDA panel to review sNDA for Vertex's Kalydeco

October 3, 2014 3:06 AM UTC

FDA's Pulmonary-Allergy Drugs Advisory Committee will meet on Oct. 21 to review an sNDA from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) for use of Kalydeco ivacaftor oral tablets to treat cystic fibrosis patients aged 18 or older with an R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. According to the company, about 300 patients in this age group have the mutation in the U.S. ...