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Vertex Receives EC’s Approval for the Label Extension of Orkambi to Treat Children with Cystic Fibrosis Aged 1 to <2 Years

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Vertex Receives EC’s Approval for the Label Extension of Orkambi to Treat Children with Cystic Fibrosis Aged 1 to <2 Years

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  • The EC has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor) to treat children with CF aged 1-<2yrs. who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
  • Orkambi was approved by regulatory authorities in the US, Great Britain, Australia, and Canada for patients aged ≤1yr. with CF and two copies of the F508del mutation in the CFTR gene
  • Additionally, the company will continue to work with reimbursement bodies across the EU, Australia, and Canada to provide access for all eligible patients

Ref: Businesswire Image: Vertex

Related News:- Vertex’s Orkambi (lumacaftor/ivacaftor) Receives EMA’s CHMP Positive Opinion for Children With Cystic Fibrosis Ages 1 to <2 Years

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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