News
Health Canada gives Trikafta priority review for cystic fibrosis in people ages 12 years and older.- Vertex Pharma
Vertex Pharmaceuticals announced its New Drug Submission for Trikafta, the investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older. With 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.Applications to the EU and FDA for marketing authorization were based on the results of two global Phase III studies, which showed statistically significant and clinically meaningful improvements in lung function (primary endpoint) and all key secondary endpoints, in people with CF ages 12 years and older with one F508del mutation and one minimal function mutation or two F508del mutations in the CFTR gene. The triple combination regimen was generally well tolerated in both studies.
Condition: Cystic Fibrosis-F508del-gene
Type: drug
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