Posted by Michael Wonder on 25 Sep 2018
Alnylam Pharmaceuticals receives priority review in Canada for patisiran, an investigational RNAi therapeutic for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy
24 September 2018 - Health Canada grants priority review to promising medicines intended for the treatment of serious, debilitating or life-threatening conditions.
Alnylam Pharmaceuticals announced today that Health Canada has granted priority review status to patisiran. Priority review is granted to regulatory filings in Canada intended for new potentially life- saving treatments where there is no existing medicine on the Canadian market or where the new medicine represents a significant improvement in the benefit/risk profile over existing products. Currently there are no approved treatments for patients with hATTR amyloidosis in Canada.
The regulatory submission in Canada for the treatment of patients with hATTR amyloidosis will be based on data from the APOLLO Phase 3 study. The randomised, double-blind, placebo-controlled, global Phase 3 is the largest-ever study conducted in hATTR amyloidosis patients with polyneuropathy, and enrolled patients in Canada. The results were published in the 5 July 2018, issue of The New England Journal of Medicine.
