10:07 AM EDT, 07/15/2024 (MT Newswires) -- Vertex Pharmaceuticals ( VRTX ) said Monday that Health Canada has approved Trikafta for treating patients aged 2 years and older with certain cystic fibrosis transmembrane conductance regulator, CFTR, gene mutations.
The marketing authorization expands the use of the drug for cystic fibrosis patients with a mutation in the CFTR gene that is responsive based on clinical and/or in vitro data. Trikafta was previously approved only for those with at least one F508del mutation, but is now approved for 152 additional mutations, the company said.
The approval is based on data from various sources, including a randomized placebo-controlled double-blind study with patients six years or older which met its primary endpoint, the company said.
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