Vertex Pharmaceuticals Incorporated has announced that Health Canada has granted Marketing Authorization for PrALYFTREKTM (vanzacaftor/tezacaftor/deutivacaftor), a next-generation CFTR modulator for cystic fibrosis treatment. Approved for patients aged six and older with at least one F508del mutation or another responsive mutation in the CFTR gene, ALYFTREK offers a once-daily treatment option. This approval is based on comprehensive Phase 3 studies demonstrating the therapy's efficacy and safety. ALYFTREK is already approved in the U.S., UK, and EU, with ongoing regulatory reviews in Switzerland, Australia, and New Zealand. Approximately 3,800 Canadians are now eligible for this new treatment, which could transform care for up to 60 individuals previously ineligible for CFTR modulators.
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