Vertex Receives European Commission Approval for ALYFTREK®, a New Once-Daily Treatment for Cystic Fibrosis
Wednesday, July 02, 2025
Vertex Pharmaceuticals has announced that the European Commission has granted approval for ALYFTREK®, a once-daily cystic fibrosis transmembrane conductance regulator (CFTR) modulator. The new treatment is intended for people with cystic fibrosis (CF) and aims to improve CFTR protein function more effectively than existing therapies.
In two key clinical trials, the combination of deutivacaftor, tezacaftor, and vanzacaftor was compared to KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) taken with ivacaftor. The results showed that ALYFTREK was non-inferior in improving lung function, measured by ppFEV1, and was more effective at reducing sweat chloride levels—a marker of improved CFTR function.
This new therapy is expected to offer an additional treatment option for people with CF, a complex, multi-organ condition. By further improving CFTR function, the medicine has the potential to enhance long-term health outcomes for eligible patients.
Following the approval, patients in Ireland and Denmark will gain early access to the therapy through existing reimbursement agreements. In countries like Germany, access will be available under current healthcare provisions. Vertex is actively engaging with reimbursement authorities across the European Union to expand access for all eligible patients as quickly as possible.
Source: businesswire.com
