Vertex Pharmaceuticals announced that the European Commission has granted approval for ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) aged 6 years and older. The approval covers patients with at least one non-class I mutation in the CFTR gene, making it the broadest label for this medicine globally.
In two head-to-head pivotal clinical trials, ALYFTREK was non-inferior to KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor on ppFEV1 and demonstrated superiority at reducing sweat chloride, indicating greater improvement in CFTR function. This new once-daily medicine has the potential to further improve outcomes for patients.
Approximately 31,000 people with CF in the EU are now eligible for this new highly effective modulator therapy. Eligible patients in Ireland and Denmark, and those with access provisions in Germany, are expected to gain access shortly, with Vertex continuing to work with reimbursement bodies across the EU.
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