Vertex Pharma Gets FDA Approval for New Ages for Cystic Fibrosis Treatment
September 25 2020 - 8:44AM
Dow Jones News
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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