Regulatory Decision Summary for Xultophy
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission is to update the Xultophy Product Monograph to include a revised indication for post-oral anti-diabetics use (post-OAD) and a new indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus at high cardiovascular risk based on the Cardiovascular Outcomes Trial results from LEADER and DEVOTE trials.
Why was the decision issued?
Over 2,500 patients with type 2 diabetes mellitus (T2DM) participated in three randomized, parallel and active- or placebo-controlled phase 3 trials (studies 3697, 3951 and 4229) of 26 weeks duration conducted in adult subjects inadequately controlled on one or more oral anti-diabetic drugs OADs.
The efficacy and safety of Xultophy were compared to that of insulin degludec and liraglutide (study 3697), placebo (study 3951), and insulin glargine (study 4229), all administered once-daily. Patients also received background T2DM therapies in theses trials, as follows: in study 3697 they received metformin ± pioglitazone; in study 3951 they received sulphonylurea ± metformin; and in study 4229 they received SGLT2i ± other OADs.
The primary efficacy endpoint (reduction in HbA1c from baseline at Week 26) was achieved in all three trials. On a background of OADs, Xultophy was superior to comparators in controlling blood glucose. The efficacy results were clinically meaningful and statistically significant.
The Xultophy safety profile was consistent with what has been seen for its two components, insulin degludec and liraglutide. No clinically important differences in risk of severe hypoglycemia between Xultophy and comparators were observed in these clinical trials.
The benefit/risk profile of Xultophy remains favourable in the target patient population.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.