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Health Canada Approves KALYDECO™ (ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis In People With A Specific Genetic Mutation (G551D)

KALYDECO can cause serious adverse reactions including abdominal pain and high liver enzymes in the blood. The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (the common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; and dizziness. These are not all the possible side effects of KALYDECO. A list of the adverse reactions can be found in the full product labeling for each country where KALYDECO is approved. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.

For country-specific product information, please see full U.S. Prescribing Information for KALYDECO at  www.KALYDECO.com, the EU Summary of Product Characteristics for KALYDECO at http://goo.gl/N3Tz4, and the KALYDECO Canadian Product Monograph at www.vrtx.ca.

About Cystic Fibrosis

Cystic fibrosis is a rare life-shortening genetic disease affecting approximately 70,000 people worldwide, including 30,000 people in the United States, 35,000 in Europe, 4,000 in Canada and nearly 3,000 in Australia. Today, the median predicted age of survival for a person with CF is approximately 37 years in the United States, about 40 years in Europe and 48 years in Canada, but the median age of death remains in the mid-20s.

There are more than 1,800 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic, or genotyping test, lead to CF by creating non-working or not enough CFTR protein at the cell surface. The absence of a working CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage.

Vertex’s Ongoing CF Research and Development Program

Vertex is conducting additional studies to evaluate ivacaftor monotherapy in patients who may benefit from improved CFTR protein function, including children with CF as young as 2 years and people with CF who have the R117H mutation or gating mutations that were not evaluated in previous Phase 3 studies.

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