EC approves Vertex's KAFTRIO + ivacaftor for cystic fibrosis in children aged 6 to 11 years
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Vertex Pharmaceuticals (NASDAQ:VRTX) announces that the European Commission (EC) has granted approval for the label extension of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients ages 6 through 11 years old.
CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract.
This medicine has also been approved by regulatory authorities in New Zealand and in Switzerland, where it is known as TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), for people with CF ages 6 and above.
Last month, Vertex reported positive VX-147 data in mid-stage focal glomerular sclerosis study.