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Vertex Pharma: FDA Approves Expanded Indication For KALYDECO - Quick Facts

Vertex Pharmaceuticals Inc. (VRTX) announced the U.S. FDA has approved an expanded indication for KALYDECO, which allows physicians to treat the underlying cause of cystic fibrosis in eligible infants as young as six months of age for the first time, with the potential to modify the course of the disease. The FDA approval is based on data from a 24-week Phase 3 open-label safety cohort.

KALYDECO is currently approved in the U.S., Canada and EU for the treatment of cystic fibrosis in patients ages 12 months and older.

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