Vertex Pharmaceuticals has announced that the European Commission has approved its newest cystic fibrosis (CF) treatment, ALYFTREK®—a once-daily, triple-combination therapy made up of deutivacaftor, tezacaftor, and vanzacaftor. This approval applies to eligible patients aged six and older who have at least one CFTR mutation responsive to treatment (excluding class I mutations). The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year.
ALYFTREK® was shown in clinical trials to be as effective as, or better than, existing therapies such as KAFTRIO® (marketed as Trikafta® in the U.S.). It matched KAFTRIO in improving lung function (measured by ppFEV₁) and surpassed it in reducing sweat chloride levels, a key biomarker of CFTR protein function. These results underscore ALYFTREK®’s strength as a next-generation option, particularly as Vertex’s earlier therapies approach patent expiration.
Already launched in the U.S. and the U.K., ALYFTREK® earned 53.9 million USD in its first U.S. sales quarter. With the European approval now secured, the treatment will first become available in Ireland, Denmark, and Germany—thanks to existing reimbursement agreements. Vertex is also working with other EU countries to expand access quickly.
This approval represents an important step forward in enhancing the quality of care for tens of thousands of European patients living with cystic fibrosis and reinforces Vertex’s commitment to innovation in CF treatment.
