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Vertex announces FDA approval for KALYDECO to treat eligible infants with CF
The Fly

Vertex announces FDA approval for KALYDECO to treat eligible infants with CF

Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration approved KALYDECO for use in children with cystic fibrosis ages 1 month to less than four months old 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 is already approved in the U.S. and EU for the treatment of CF in patients ages four months and older. "Treating the underlying cause of cystic fibrosis as early as possible is important, and this approval, the first for a CFTR modulator in this age group, means families will now have a medicine for eligible infants," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex.

Published first on TheFly

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