By Chris Wack

 

Vertex Pharmaceuticals Inc. said Friday the U.S. Food and Drug Administration approved Kalydeco ivacaftor for use in children with cystic fibrosis ages four months to less than six months old.

The company said Kalydeco is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older.

Vertex said this FDA approval is based on data from a cohort in the 24-week Phase 3 open-label safety cohort consisting of six children with CF ages four months to less than six months who have one of 10 mutations in the CFTR gene. This cohort demonstrated a safety profile similar to that observed in older children and adults.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

September 25, 2020 08:29 ET (12:29 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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