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Vertex announces acceptance of NDS for exagamglogene autotemcel
The Fly

Vertex announces acceptance of NDS for exagamglogene autotemcel

Vertex Pharmaceuticals Incorporated announced its New Drug Submission for exagamglogene autotemcel has been accepted for Priority Review by Health Canada for the treatment of patients aged 12 years and older with sickle cell disease with recurrent vaso-occlusive crises and for the treatment of patients aged 12 years and older with transfusion-dependent beta thalassemia.The NDS will be part of an aligned review with Health Technology Assessment organizations, the Canadian Agency for Drugs and Technologies in Health and the Institut national d’excellence en sante et en services sociaux in Quebec. With Priority Review, the conventional review timeline of 300 days is reduced to 180 days.

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