Regulatory Decision Summary for Xultophy
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.
Type of submission:
What was the purpose of this submission?
The purpose of this submission was to seek marketing authorisation for Xultophy (insulin degludec / liraglutide) in adult patients with type 2 diabetes mellitus (T2DM).
Why was the decision issued?
In adult subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled on metformin (± sulfonylurea) plus basal insulin (two trials) or liraglutide (one trial), a statistically significant reduction in HbA1c at Week 26 was demonstrated with Xultophy versus comparator.
All trials had design limitations, including but not limited to the choice of comparator, inadequate comparator dosing regimens, and sub-optimal treatment dose. Hence, the interpretation of the efficacy data cannot be extrapolated to all patients with T2DM and is limited to the patient population studied in the clinical trials. These limitations were captured in the Product Monograph.
The overall safety profile of Xultophy is consistent with the known safety profiles of the two components of the drug: insulin degludec and liraglutide. The clinical data did not suggest an increased incidence of risks identified.
Based on the clinical data evaluated and as labelled, the benefits of Xultophy in the target population and for the indication authorized outweigh its risks. The overall benefit/risk profile of Xultophy is considered to be favourable.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.