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Vertex Pharma Gets Approval for Cystic Fibrosis Drug for Infants in Canada

By Kimberly Chin

 

Vertex Pharmaceuticals Inc. was given approval to market its drug that treats children as young as four months of age with cystic fibrosis in Canada.

Health Canada gave the biotechnology company marketing authorization for Ivacaftor, which goes by the brand name Kalydeco. It is one of the first medicines to treat the underlying cause of cystic fibrosis in people that have specific mutations in the cystic fibrosis transmembrane conductance gene, the company said.

The drug is now approved for additional eligible patients in Canada, Vertex said.

"With today's approval, children in Canada as young as 4 months now have a medicine to treat the underlying cause of their disease," said Chief Regulatory and Quality Officer Nia Tatsis in prepared remarks.

Cystic fibrosis is a genetic disease that can affect the lungs, liver, gastrointestinal tract, sinuses, reproductive tract and other areas of the body. The defective or absent CFTR proteins can lead to abnormally thick muscus that cause infections and damage organs.

 

Write to Kimberly Chin at kimberly.chin@wsj.com

 

(END) Dow Jones Newswires

August 25, 2021 16:17 ET (20:17 GMT)

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