Canada Prioritizes Review of Kalydeco for Children With R117H Mutation

Canada Prioritizes Review of Kalydeco for Children With R117H Mutation

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Canada Prioritizes Review of Kalydeco for Children With R117H Mutation

Health Canada has granted priority review to Vertex Pharmaceuticals’ application seeking the approval of Kalydeco (ivacaftor) to treat cystic fibrosis (CF) patients, ages 4 months to 18 years, carrying the R117H mutation in the CFTR gene. The intended label extension is for patients who weigh at least 5 kilograms (about 11 pounds), according to the company’s press release. “We are pleased this submission has been accepted for Priority Review by Health Canada, and we hope that this…

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