Posted by Michael Wonder on 29 Mar 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis with at least one F508del mutation
26 March 2021 - If approved, people ages 12 years and older who have one copy of the F508del mutation and a gating or residual function mutation will now be eligible for triple combination therapy.
Vertex Pharmaceuticals today announced that the EMA's CHMP adopted a positive opinion for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene, the most common cystic fibrosis causing mutation worldwide.
