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Vertex's TRIKAFTA Accepted For Priority Review By Canada For Treatment Of Cystic Fibrosis

Vertex Pharmaceuticals Inc. (VRTX) said Monday that its New Drug Submission for TRIKAFTA is accepted for Priority Review by Health Canada. TRIKAFTA is the company's investigational triple combination medicine for the treatment of cystic fibrosis in people ages 12 years and older.

Following the acceptance of Priority Review, the conventional review timeline of 300 days is reduced to 180 days. The expected approval target by Health Canada is in the first half of 2021.

Cystic fibrosis is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide.

Cystic fibrosis is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. Cystic fibrosis is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene.

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