23.02.2024 14:56:21 - dpa-AFX: Vertex's Kalydeco Gets CHMP Positive Opinion For Label Expansion To Cystic Fibrosis In Infants
CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Friday, Vertex Pharmaceuticals Inc.
(VRTX) announced that the Committee for Medicinal Products for Human Use or CHMP
of the European Medicines Agency has granted a positive opinion for expanding
the label of Kalydeco, also known as ivacaftor.
This expansion would allow the treatment of infants with cystic fibrosis who are
between 1 month and less than 4 months old and have specific mutations in the
cystic fibrosis transmembrane conductance regulator gene.
Currently, Kalydeco is a prescription medicine used for the treatment of cystic
fibrosis in patients aged at least 4 months and older.
Additionally, the company disclosed that Kalydeco is already approved in the
European Union for treating individuals with cystic fibrosis and have specific
mutations.
Copyright(c) 2024 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX