Regulatory Decision Summary for Bimzelx

The purpose of this submission is to seek market authorization for Bimzelx for the treatment of adult patients with active axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS, radiographic spondyloarthritis) and nonradiographic axial spondyloarthritis (nr-axSpA).

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

The efficacy and safety of Bimzelx were evaluated in 586 adult patients with active axial spondyloarthritis (axSpA) in two multicenter, randomized, double-blind, placebo-controlled studies. In both studies, patients had active disease as defined by a BASDAI ≥4 and spinal pain ≥4 on a 0 to 10 numeric rating scale (NRS), as well as a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance or contraindication to NSAIDs.

The BE MOBILE 1 study evaluated 254 patients with active nr-axSpA. Patients had axSpA meeting the ASAS classification criteria, with and no evidence of radiographic changes in the sacroiliac joints that would meet the modified New York criteria for AS. Patients also had objective signs of inflammation as indicated by elevated C-reactive protein (CRP) level and/or evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).

The BE MOBILE 2 study evaluated 332 patients with active AS. Patients had AS meeting the Modified New York criteria for AS including radiologic evidence. Overall 16.3% of patients were previously treated with an anti-TNFα agent.

The primary efficacy endpoint in both studies was the percentage of patients achieving an Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 16. Key secondary endpoints were also evaluated. The efficacy results were clinically meaningful and statistically significant for the primary and key secondary endpoints, in both axSpA studies. Treatment with Bimzelx 160 mg Q4W resulted in significant improvement in signs and symptoms, and in measures of disease activity compared to placebo at Week 16 in both nr-axSpA and AS patient populations. In AS patients, a similar ASAS 40 response was seen regardless of prior anti-TNFα exposure.

Data from placebo-controlled studies in non-radiographic axial spondyloarthritis (BE MOBILE 1) and in ankylosing spondylitis (BE MOBILE 2) were pooled to evaluate the safety of Bimzelx for up to 16 weeks. The most frequently reported adverse events in the Bimzelx vs. placebo groups were diarrhea, injection site reactions, nasopharyngitis, oral candidiasis, headache, rash, and dermatitis and eczema. Infections were reported in 30.4% of patients treated with Bimzelx for up to 16 weeks compared with 23.6% of patients treated with placebo. Fungal infections were reported in 6.3% of patients treated with Bimzelx for up to 16 weeks compared with 0% of patients treated with placebo; this is consistent with the safety profile of Bimzelx in the authorized indications.

Both the AS and nr-axSpA patients treated with Bimzelx up to 24 weeks at the recommended dosing regimen had anti-drug antibodies. No clinically meaningful impact on PK, clinical response, or safety profile was associated with anti-bimekizumab antibodies or neutralizing antibodies development.

Overall, the benefits of Bimzelx outweigh its risks in adult patients with axSpA. The benefit/risk profile of the drug is considered favourable in the target patient population.

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.