Regulatory Decision Summary for EPERZAN
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 EPERZAN for the treatment of adult patients with type 2 diabetes mellitus (T2DM), as adjunct to diet and exercise to improve glycemic control. EPERZAN is indicated in combination therapy with metformin, sulfonylurea or insulin. It also indicated as monotherapy when metformin is inadequate due to contraindication or intolerance.
Why was the decision issued?
The efficacy and safety of EPERZAN was evaluated in several clinical trials in which patients at different stages of the disease were treated with EPERZAN in combination with commonly-used classes of T2DM treatment including metformin, sulfonylurea or basal insulin. EPERZAN was also studied in patients with renal impairment. Treatment with EPERZAN, as add-on to therapies mentioned above, reduced glycated hemoglobin (HbA1c) and fasting plasma glucose in patients with T2DM.
EPERZAN is supplied as a solution for subcutaneous injection. The recommended dose is 30 mg once weekly given as a subcutaneous injection. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.
EPERZAN 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. EPERZAN 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 EPERZAN was found to be similar to other marketed GLP-1 agonists in Canada. Therefore, the overall benefit/risk of EPERZAN 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.