Hero image

HISTORY OF ORKAMBI®

ORKAMBI has been studied in multiple trials in people of specific ages who have 2 copies of the F508del mutation. It was the first medicine approved to treat the underlying cause of cystic fibrosis (CF) in people with 2 copies of the F508del mutation. 
 


Person with a book icon
2015

ORKAMBI was approved to treat people with CF age 12 and older who have 2 copies of the F508del mutation.

Person and dog icon
2016

ORKAMBI was approved to treat children age 6 through 11 years who have 2 copies of the F508del mutation, based on an additional safety study.

Person with a book icon
2018

ORKAMBI was approved to treat children age 2 through 5 years who have 2 copies of the F508del mutation, based on an additional safety study.

Person and teddy bear icon
2022

ORKAMBI was approved to treat children age 1 through 2 years who have 2 copies of the F508del mutation, based on an additional safety study.