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.
Product type:
Drug
Medicinal ingredient(s):
Dulaglutide
Therapeutic area:
A10
Type of submission:
Supplement to a New Drug Submission
Control number:
255495
What was the purpose of this submission?
This purpose of this submission was to seek authorization for two additional (higher) maintenance dose levels and two higher-strength formulations of Trulicity (dulaglutide) for adults with type 2 diabetes mellitus requiring additional glycemic control.
Why was the decision issued?
- There was no change to the authorized indications for Trulicity in this submission.
- Authorization of the 3.0 mg (6 mg/mL) and 4.5 mg (9 mg/mL) dose levels and formulations was based on 3 clinical studies, including a 52-week Phase 3 study (Study GBGL).
- Study GBGL randomized 1,842 patients to receive double-blind treatment with maintenance doses of 1.5 mg/week, 3.0 mg/week, or 4.5 mg/week dulaglutide.
- The primary endpoint was change from baseline HbA1c at Week 36 of treatment. Patients in the 4.5 mg/week arm showed a statistically significant increase in treatment effect compared to patients receiving 1.5 mg/week, and patients receiving 3.0 mg/week showed a numerical increase in treatment effect compared to the 1.5 mg/week arm.
- Secondary and exploratory endpoints showed a consistent and sustained dose-related effect related to glycemic control and body weight across the three dose levels over the 52 weeks of treatment.
- The most common adverse reactions were gastrointestinal in nature, which is consistent with the established profile for dulaglutide. The dose escalation protocol at treatment onset is intended to decrease the incidence of these effects. No new safety signals were identified in study GBGL with the use of the higher (3.0 mg/week and 4.5 mg/week) dose levels.
- The recommended maintenance dose of Trulicity is 1.5 mg/week. Patients requiring additional glycemic control may increase their dose to 3 mg/week after a minimum of 4 weeks on the 1.5 mg/week dose if needed. Patients requiring additional glycemic control may further increase their dose to a maximum dose of 4.5 mg/week after a minimum of 4 weeks on the 3 mg/week dose.
- In the indicated adult patient population, the benefit-risk profile of Trulicity is positive at maintenance doses up to 4.5 mg/week.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TRULICITY | 02530163 | ELI LILLY CANADA INC | DULAGLUTIDE 3 MG / 0.5 ML |
| TRULICITY | 02530171 | ELI LILLY CANADA INC | DULAGLUTIDE 4.5 MG / 0.5 ML |