Regulatory Decision Summary for Ozempic
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?
Ozempic is currently indicated for the once-weekly treatment of adult patients with T2DM to improve glycemic control, in combination with:
- diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance;
- metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control;
- metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control; and
- basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control.
The purpose of the submission was to add an indication to the current authorized use of Ozempic:
For concomitant use with a sodium glucose cotransporter 2 inhibitor (SGLTi) and metformin or sulfonylurea in adult patients with type 2 diabetes mellitus (T2DM).
Why was the decision issued?
Authorization was based on a randomized controlled trial (Study NN9535-4269 or SUSTAIN 9) that evaluated the efficacy and safety of Ozempic in adult T2DM patients who had inadequate glycemic control (HbA1c 7.0-10.0%) on SGLT2 inhibitor with metformin or sulfonylurea.
The trial showed that treatment with Ozempic resulted in a statistically significant greater reduction in HbA1c from baseline compared to placebo, in combination with SGLT2 inhibitor with metformin or sulfonylurea.
The increased hypoglycemic events observed in the Ozempic group compared to the placebo group are labelled and will be monitored as part of post-market surveillance.
Other than hypoglycemic events, no other emergent safety issue was identified.
The overall benefit-risk profile of the use of Ozempic as concurrent therapy with SGLT2 inhibitor and metformin or sulfonylurea is, therefore, considered acceptable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations as per the Notice of Compliance with Conditions Guidance.