Regulatory Decision Summary for Bimzelx

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:


Medicinal Ingredient(s):


Control Number:


Brand/Product Name:


Therapeutic Area:


Type of Submission:

Supplement to a New Drug Submission

Decision Issued:

Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations

What was the purpose of this submission?

The purpose of this submission was to seek market authorization for an additional indication for adult patients of active psoriatic arthritis (PsA) for Bimzelx (bimekizumab).

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

Why was the decision issued?

Authorization was based on two phase 3 clinical studies that were, international, multi-centre, randomized, double-blind, placebo-controlled trials evaluating approximately 1200 patients with active psoriatic arthritis. The studies evaluated Bimzelx used at a dose of 160 mg every 4 weeks for up to 52 weeks.

The primary efficacy endpoint (American College of Rheumatology 50% improvement criteria (ACR50) response) was evaluated at 16 weeks and found to be statistically significantly different compared to placebo. Compared to placebo, Bimzelx treatment was associated with a higher ACR50 response rate and improved clinical outcomes from baseline.

The most frequently reported adverse events in the development program were related to infections and infestations. The most frequently reported TEAEs were upper respiratory tract infections and headaches. No new safety concerns were identified from the evaluation of the clinical data provided to Health Canada in this submission. The safety profile was consistent with previously reported data and properly labelled in the product monograph.

Overall, based on the data evaluated as part of this submission, the benefit-risk profile of Bimzelx is considered to be favourable for the treatment of adult patients of active psoriatic arthritis (PsA).

A Risk Management Plan (RMP) for Bimzelx was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Bimzelx, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

Date of Decision:



UCB Canada Inc.

Drug Identification Number(s) Issued:


Prescription Status:

Available by prescription only

Date Filed: