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?
The purpose of this NDS is to seek market authorization of TRULICITY for the treatment of adult patients with type 2 diabetes mellitus (T2DM), as adjunct to diet and exercise to improve glycemic control. TRULICITY is indicated in combination therapy with metformin, metformin plus sulfonylurea or metformin plus prandial insulin. It also indicated as adjunct to diet and exercise when metformin is inadequate due to contraindication or intolerance.
Why was the decision issued?
The efficacy and safety of TRULICITY was evaluated in several clinical trials in which patients were treated with TRULICITY in combination with commonly-used classes of T2DM treatment including metformin, sulfonylurea or prandial insulin. TRULICITY was also studied in patients with renal impairment. Treatment with TRULICITY, as add-on to therapies mentioned above, reduced glycated hemoglobin (HbA1c) and fasting plasma glucose in patients with T2DM.
TRULICITY is not indicated in patients with type 1 diabetes mellitus or diabetic ketoacidosis. The Canadian Labelling of this drug will also carry a boxed warning stating that thyroid C-cell tumors have been observed in animal studies with other drugs of the same class (GLP-1 agonists) but that it is unknown whether this particular product causes these types of tumors, including medullary thyroid carcinoma (MTC) in humans. TRULICITY should not be used in patients who have a personal or family history of MTC or have multiple endocrine neoplasia syndrome type 2 and in pregnant and nursing women.
The safety profile of TRULICITY was found to be similar to other marketed GLP-1 agonists in Canada. Therefore, the overall Benefit/Risk of TRULICITY is considered acceptable for the proposed indications. In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TRULICITY | 02448599 | ELI LILLY CANADA INC | DULAGLUTIDE 0.75 MG / 0.5 ML |
| TRULICITY | 02448602 | ELI LILLY CANADA INC | DULAGLUTIDE 1.5 MG / 0.5 ML |