Regulatory Decision Summary for TOUJEO SoloSTAR
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.
Product type:
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Type of submission:
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What was the purpose of this submission?
The purpose of this new drug submission (NDS) is to seek market authorization of TOUJEO for the treatment of adult patients with type 1 or type 2 diabetes mellitus who require basal insulin to control hyperglycemia.
Why was the decision issued?
Treatment with TOUJEO reduced glycated hemoglobin (HbA1c) and fasting plasma glucose levels. The mean reduction in HbA1c was comparable to that with LANTUS in patients with type 1 or type 2 diabetes mellitus. When switching from LANTUS to TOUJEO, the starting dose of TOUJEO can be the same dose (in units) as the LANTUS but may require adjustment of dose to achieve glycemic target. The advantage of TOUJEO over LANTUS is the lower injected volume which may benefit some patients who require high dose of insulin. TOUJEO and LANTUS are not interchangeable. The safety profile of TOUJEO was found to be similar to LANTUS. The potential risk for medication error has been appropriately addressed in the Product Monograph. Therefore, the overall Benefit/Risk of TOUJEO is considered acceptable for the proposed indication.
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 |
|---|---|---|---|
| TOUJEO SOLOSTAR | 02441829 | SANOFI-AVENTIS CANADA INC | INSULIN GLARGINE 300 UNIT / ML |