Novo Nordisk will make Awiqli (insulin icodec injection) available in Canada, marking the global debut of the world’s first once-weekly basal insulin.
Credit: CNW Group/Novo Nordisk Canada Inc.
Scheduled for nationwide availability starting June 30, 2024, Awiqli has received approval from Health Canada.
Diabetes mellitus, a condition affecting over 4.1 million Canadians, demands continual treatment evolution due to its increasing prevalence and associated health and economic burdens. This milestone represents a significant advancement in diabetes management, offering patients the convenience of transitioning from daily to weekly basal insulin injections.
Awiqli® – world’s first once-weekly basal insulin – now available in Canada. (CNW Group/Novo Nordisk Canada Inc.)
Per the news release, Awiqli’s approval follows successful outcomes from the ONWARDS phase 3a clinical trials, involving over 4,000 adults globally. These trials demonstrated efficacy in meeting primary endpoints, supporting its safety profile despite common adverse reactions such as hypoglycemia and injection-site reactions.
According to Health Canada’s decision based on the results of the trial, patients with Type 2 diabetes treated with Awiqli exhibited comparable or superior outcomes in various glycemic measures without severe hypoglycemia, whereas those with Type 1 diabetes showed a higher incidence of hypoglycemic events.
Despite the favourable benefit-risk profile established through rigorous evaluation and risk management strategies, Awiqli users, particularly in the initial days of the weekly dosing cycle, may experience an elevated incidence of hypoglycemia. Health Canada says Novo Nordisk has incorporated these findings into the approved Product Monograph.