Health Canada has granted market Authorization for the expanded use of Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF) in certain children ages 2 months and older, according to Vertex Pharmaceuticals Inc, manufacturer of Kalydeco, in a release.
To be eligible, patients must weigh at least 3 kg and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H.
“For the first time, children with specific mutations will be eligible at 2 months of age for a medicine that treats the underlying cause of their cystic fibrosis,” says Michael Siauw, general manager at Vertex Pharmaceuticals (Canada), in a release. “We remain committed to researching and developing medicines for younger CF patients, and this important approval highlights our continued dedication and progress.”
Vertex says it will work with government and private payers to facilitate access for eligible patients as soon as possible.
Kalydeco was previously approved by Health Canada for use in people with CF ages 4 months and older who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R or R117H.
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