Posted by Michael Wonder on 25 Nov 2023
Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license.
Vertex Pharmaceuticals today announced that the EMA has validated a type II variation application to the marketing authorisation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor.
