12:15 PM EDT, 04/01/2024 (MT Newswires) -- Vertex Pharmaceuticals ( VRTX ) said Monday that Health Canada has accepted the company's New Drug Submission for exagamglogene autotemcel for priority review.
The treatment targets patients aged 12 years and older with sickle cell disease experiencing recurrent vaso-occlusive crises and those with transfusion-dependent beta thalassemia, the company said.
The priority review slashes the standard 300-day timeline to just 180 days, Vertex said, adding that the submission is supported by phase 3 studies CLIMB-111 and CLIMB-121, along with ongoing long-term follow-up study CLIMB-131.
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