FDA Approves Kalydeco for Use In Patients With Eight Other Gene Mutations

Vertex Pharmaceuticals Inc. Feb. 21 said that the Food and Drug Administration has approved a supplemental new drug application for Kalydeco (ivacaftor) for people with cystic fibrosis (CF) ages six and older who have one of eight mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Kalydeco first was approved in January 2012 for people with CF ages six and older who have at least one copy of the G551D gene mutation 10 PLIR 144, 2/3/12.

With the approval of the sNDA, Kalydeco now is approved for people with CF with these nine mutations: G551D, G178R, S549N, S549R, ...