European Commission Approves Vertex’s ALYFTREK® — A Next-Gen Breakthrough in Cystic Fibrosis Therapy

Vertex Pharmaceuticals has announced that the European Commission has granted marketing authorization for its next-generation cystic fibrosis (CF) treatment, ALYFTREK®. This once-daily triple-combination therapy includes deutivacaftor, tezacaftor, and vanzacaftor, and is now approved for patients aged six years and older with at least one responsive CFTR mutation (excluding class I mutations).
The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and marks a significant milestone in the ongoing advancement of CF treatment.
In clinical trials, ALYFTREK® demonstrated comparable or superior efficacy to KAFTRIO® (marketed as Trikafta® in the U.S.). It matched KAFTRIO’s performance in improving lung function, measured by percent predicted forced expiratory volume in one second (ppFEV₁), and exceeded it in lowering sweat chloride levels, a crucial biomarker indicating improved CFTR protein activity.
As Vertex’s older CF therapies approach patent expiration, ALYFTREK® is emerging as a next-generation cornerstone in CF management. The drug has already been launched in the U.S. and U.K., generating $53.9 million in U.S. sales in its first quarter.
With European approval secured, ALYFTREK® will first roll out in Ireland, Denmark, and Germany, where reimbursement agreements are already in place. Vertex is actively working with health authorities in other EU countries to accelerate access across the region.

“This approval represents a major step forward for thousands of people in Europe living with CF,” said a Vertex spokesperson. “It highlights our ongoing commitment to scientific innovation and improving long-term outcomes for patients.”

ALYFTREK® now joins Vertex’s portfolio of transformative CF treatments and strengthens its leadership in addressing the complex and evolving needs of the cystic fibrosis community.