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