Benzinga | Sep 22, 2021 11:18AM EDT

Vertex's Supplement to a New Drug Submission for KALYDECO (ivacaftor) for Patients with Cystic Fibrosis Between the Ages of 4 Months and 18 Years with the R117H Mutation in the CFTR Gene Accepted for Priority Review by Health Canada

Vertex Pharmaceuticals Incorporated (Canada) (NASDAQ:VRTX) today announced its Supplement to a New Drug Submission for PrKALYDECO(r) (ivacaftor) has been accepted for priority review by Health Canada for the treatment of cystic fibrosis (CF) in patients from 4 months to 18 years of age and weighing at least 5 kg with the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

"We are pleased this submission has been accepted for Priority Review by Health Canada, and we hope that this will enable access for patients with the R117H mutation as soon as possible," said Duncan McKechnie, Senior Vice President, North America Commercial Operations, Vertex Pharmaceuticals. "It's our goal to ensure as many people as possible with cystic fibrosis are able to access treatments for the underlying cause of their CF."