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Phase 3 Studies of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis Ages 12 and Older Published in the New England Journal of Medicine

 

November 3, 2017

We are excited to announce that the New England Journal of Medicine (NEJM) published two articles with results from two Phase 3 studies of the tezacaftor/ivacaftor combination treatment, a medicine in development that is designed to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The results were published in two online articles in conjunction with two oral presentations at the 31st Annual North American Cystic Fibrosis Conference. These data formed the basis of applications for the approval of the tezacaftor/ivacaftor combination that are currently under review with regulatory agencies in the United States and Europe. In the United States, the Food and Drug Administration (FDA) has granted Priority Review of the application and has set an action date of February 28, 2018.