Vertex Gets FDA Approval for Kalydeco To Treat Infants With CF

Vertex says the U.S. FDA approved Kalydeco for use in children with cystic fibrosis ages 1 month to less than four months.

• Approval for infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to Kalydeco based on clinical and/or in vitro assay data
• Kalydeco already approved in the U.S. and EU for the treatment of CF in patients ages four months and older

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