Vertex Announces U.S. FDA Approval for ORKAMBI for child cystic fibrosis

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of ORKAMBI® (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to <24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. ORKAMBI® was previously approved by the FDA for use in people with CF ages 2 years and older with two copies of the F508del mutation.

https://www.businesswire.com/news/home/20220902005252/en/Vertex-Announces-U.S.-FDA-Approval-for-ORKAMBI%C2%AE-lumacaftorivacaftor-in-Children-With-Cystic-Fibrosis-Ages-12-to-24-months