Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 31, Status: Authorised

The EU approval of Kaftrio for cystic fibrosis patients with specific gene mutations signifies a significant regulatory milestone. This approval validates the positive clinical study results, offering a new treatment option for patients and highlighting Vertex Pharmaceuticals' commitment to addressing unmet medical needs in the cystic fibrosis space.