The most common serious adverse events included abdominal pain, increased liver enzymes and low blood sugar, which occurred in less than 1 percent of patients. Adverse events commonly observed in those taking KALYDECO included headache, upper respiratory tract infection (common cold), stomach pain and diarrhea. Fewer people in the KALYDECO treatment groups discontinued treatment due to adverse events than in the placebo group. The majority of adverse events associated with KALYDECO were mild to moderate.“Health Canada’s approval of KALYDECO is a welcome first step to getting Canadian CF patients access to this important advance in treatment,” said Ken Chan, Vice President, Advocacy, Research and Healthcare of Cystic Fibrosis Canada. “We are pleased that advances in CF research have led to the development of innovative, personalized new medicines such as KALYDECO. We look forward to working with Vertex and Canada’s publicly-funded drug plans to provide patients with access to KALYDECO.”
Health Canada Approves KALYDECO™ (ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis In People With A Specific Genetic Mutation (G551D)
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