Regulatory Decision Summary for Bimzelx

Plaque psoriasis is a multifactorial, relapsing immune-mediated inflammatory condition that primarily targets the skin, but has significant secondary effects on physical and mental well-being. Plaque psoriasis affects approximately 3% of the general population in Canada. Of patients diagnosed with chronic plaque psoriasis, approximately 1 in 5 have a moderate or severe form of the condition associated with marked skin plaques, itching, and pain, as well as comorbidities including mental health effects (e.g., depression, anxiety, and suicidality), cardiovascular disease, obesity, type 2 diabetes, arthritis, and chronic renal disease. Despite the number of currently available therapies for plaque psoriasis, t there remains a need for additional therapies that can provide clinically meaningful improvement in the management of moderate to severe plaque psoriasis.

The benefits of bimekizumab in the treatment of moderate to severe plaque psoriasis are primarily based on clinical data from three randomized, double-blind, active- and placebo-controlled trials, PS0008 (adalimumab), PS0009 (ustekinumab and placebo), and PS0013 (placebo), that enrolled a total of 1480 subjects 18 years of age and older. All three trials assessed the superiority of bimekizumab compared to active-comparator and/or placebo through the co-primary endpoints: i) the change in the proportion of patients with an Investigator’s Global Assessment response clear (0) with at least a 2-category improvement relative to Baseline (IGA 0) (clear) or 1 (almost clear) with at least a 2-category improvement relative to baseline; and ii) the proportion of patients achieving PASI90 (≥90% reduction in Psoriasis Area and Severity Index (PASI) score from baseline), at Week 16. Bimekizumab demonstrated statistically significant and clinically meaningful improvement in Investigator’s Global Assessment response clear (0) or almost clear (1) with at least a 2-category improvement relative to Baseline (IGA 0/1) and PASI90 responses compared to placebo, adalimumab, and ustekinumab; in responding subjects, efficacy was sustained for up to one year. Secondary endpoints measuring complete response (i.e. IGA 0 and PASI complete response [100% improvement from Baseline in the PASI score] (PASI100), overall disease symptoms/signs and severity, patient-perceived symptoms, health-related quality of life, and plaque psoriasis on areas of high impact were all supportive of a favourable benefit associated with bimekizumab.

The risks associated with bimekizumab include infections, primarily fungal infections (oral candidiasis, tinea infections) as well as opportunistic infections (localized mucocutaneous infections), relative to placebo or active-comparator treatment. The increased frequency reported in bimekizumab treated patients has been labelled in the product monograph. Based on data submitted at this time, there does not appear to be a clinically meaningful difference in the incidence of malignancy or major adverse cardiac event (MACE) in bimekizumab treated patients compared to active comparator treated patients; however, longer-term exposure data were not available at the time of submission. These potential risks are considered mitigated through labelling and post-market pharmacovigilance.

The recommended dose of the drug is 320 mg (given as 2 subcutaneous injections of 160 mg each) every 4 weeks for the first 16 weeks, and every 8 weeks thereafter. For patients with a body weight ≥ 120 kg and who did not achieve a complete skin response, a dose of 320 mg every 4 weeks after Week 16 may be considered. View the Product Monograph for details.

Overall, based on the data evaluated as part of this submission, the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) considers there to be sufficient evidence at this time to conclude that the benefit-risk profile for Bimzelx (bimekizumab injection) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy is considered favourable.

For more information on Health Canadas decision, please view the Summary Basis of Decision.