Vertex's Kalydeco Gets CHMP Positive Opinion For Label Expansion To Cystic Fibrosis In Infants

(RTTNews) - Friday, Vertex Pharmaceuticals Inc. (VRTX) announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has granted a positive opinion for expanding the label of Kalydeco, also known as ivacaftor.

This expansion would allow the treatment of infants with cystic fibrosis who are between 1 month and less than 4 months old and have specific mutations in the cystic fibrosis transmembrane conductance regulator gene.

Currently, Kalydeco is a prescription medicine used for the treatment of cystic fibrosis in patients aged at least 4 months and older.

Additionally, the company disclosed that Kalydeco is already approved in the European Union for treating individuals with cystic fibrosis and have specific mutations.