Vertex Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor) for people with cystic fibrosis aged six and older who have at least one non-class I mutation in the CFTR gene. Clinical trials showed that ALYFTREK was non-inferior to KAFTRIO in improving lung function (ppFEV1) and superior at lowering sweat chloride levels, a key indicator of disease severity. ALYFTREK is already licensed in the U.S. and UK and is under review in several other countries. If approved, the therapy could expand treatment eligibility to more patients by achieving closer-to-normal sweat chloride levels.