Vertex Receives the Health Canada Marketing Authorization for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis
- Health Canada has granted marketing authorization for the expanded use of Trikafta in children aged 6 through 11yr. with CF with at least 1 F508del mutation in the CFTR gene. Trikafta is available as elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg & ivacaftor 75mg
- The results from the P-III study showed that the regimen was well tolerated & safety data were similar to previous studies in patients aged ≥12yrs. who have either 2 F508del mutations or 1 F508del mutation & 1 minimal function mutation @24wks.
- The company has submitted the report to CADTH & INESSS in Québec for health technology assessments. Trikafta is designed to increase the quantity and function of the CFTR protein at the cell surface
Ref: Businesswire | Image: Vertex
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