Regulatory Decision Summary for Trulicity
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?
This Supplemental New Drug Submission (SNDS) was filed to seek market authorization for Trulicity (dulaglutide) in combination with basal insulin and metformin, when diet and exercise plus basal insulin with or without metformin, do not achieve adequate glycemic control in adult patients with type 2 diabetes mellitus (T2D).
Trulicity is currently authorized for T2D in combination with metformin, metformin and sulfonylurea, and prandial insulin with or without metformin.
Why was the decision issued?
Trulicity (dulaglutide) is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist indicated as a once-weekly treatment of adult patients with type 2 diabetes mellitus (T2D) to improve glycemic control. GLP-1 receptor agonists are one of several classes of anti-hyperglycemic agents indicated for treatment of T2D. Trulicity is currently authorized for T2D in combination with metformin, metformin and sulfonylurea, and prandial insulin with or without metformin.
Management of T2D involves controlling serum glucose and minimizing side effects such as body weight gain and hypoglycemia. Due to the progressive nature of the disease, many patients require combining multiple anti-hyperglycemic agents to control their disease and/or minimize side effects.
This Supplemental New Drug Submission (SNDS) provided results from study AWARD-9 supporting the expansion of Trulicitys use in combination with basal insulin (insulin glargine) with metformin - a new combination treatment option for adults with T2D who are inadequately controlled by current glucose-lowering agents.
In this study, the safety profile of the Trulicity/insulin glargine combination was shown to be comparable to the placebo/insulin glargine combination and is consistent with the approved Trulicity combinations.
The risk/benefit profile of the Trulicity/insulin glargine combination is considered favourable.
Therefore, a Notice of Compliance (NOC) has been issued.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.