Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Shots:

  • Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs.
  • With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is in H1’21
  • Trikafta is a triple combination regimen used to treat CF in patients aged ≥12yrs. who have at least one copy of the F508del mutation in the CFTR gene

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The post Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis first appeared on PharmaShots.