Vertex’s Orkambi (lumacaftor/ivacaftor) Receives Health Canada’s Market Authorization for Children with Cystic Fibrosis Aged 1 to <2 Years
Shots:
- The company received marketing authorization from Health Canada for expanded use of Orkambi to treat cystic fibrosis in children aged 1-<2yrs. who have 2 copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene
- The approved label expansion was based on the results from the 24wk. P-III study evaluating Orkambi in 46 children aged 1 to <2yrs. which showed that the therapy was found to be well tolerated & the safety profile and PK were similar to prior reported studies in patients aged ≥2yrs.
- The company will collaborate closely with payers to secure access for this new patient population shortly. Orkambi was approved by Health Canada for patients aged ≥2yrs. with CF with 2 copies of the F508del mutation
Ref: Newswire | Image: Vertex
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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.
