Regulatory Decision Summary for Victoza

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):

liraglutide

Therapeutic area:

Anti-diabetic agent

Type of submission:

Supplemental New Drug Submission

Control number:

196457
What was the purpose of this submission?

 

This Supplemental New Drug Submission (SNDS) was filed to extend the marketing authorization of Victoza in a restricted monotherapy setting for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance.

 

Why was the decision issued?

 

The safety and efficacy of Victoza, when used as monotherapy, was assessed in one 52-week, randomized, double-blind, active-controlled study in adult patients with type 2 diabetes. Based on the results from this study, Victoza demonstrated a reduction in HbA1c from baseline that was statistically superior to glimepiride after 52 weeks of treatment.

Victoza should be initiated with a dose of 0.6 mg once daily for at least one week. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg once daily. Based on the clinical response and after at least one week, the dose can be increased to 1.8 mg once daily to achieve maximum efficacy for glycemic control.

No overall differences were observed in the safety of Victoza when used as monotherapy compared to the previously authorized indication for use of Victoza in combination with other oral anti-diabetic agents (metformin, or metformin + sulfonylurea). The safety and efficacy of Victoza was further supported by over six years of post-marketing experience. Therefore, the benefit/risk ratio of Victoza is considered favourable when used in combination with diet and exercise in patients for whom metformin is inappropriate due to contraindication of intolerance. In order to ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required standard post-approval activities to be carried out as well as a Risk Management Plan.

 

Decision issued

Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.