Vertex submits NDA, MAA for Kalydeco/lumacaftor

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) submitted an NDA to FDA and an MAA to EMA for the combination of 250 mg Kalydeco ivacaftor and 400 mg lumacaftor ( VX-809) to treat cystic fibrosis (CF) in patients ages 12 and older with two copies of the F508del mutation in the CF transmembrane conductance regulator gene.

CHMP has granted accelerated assessment to the combination. Vertex is seeking Priority Review from FDA, which has granted breakthrough therapy designation to the combo. ...