Health Canada approves Bimzelx to treat plaque psoriasis.
UCB Canada Inc. announced that Health Canada has approved Bimzelx(bimekizumab injection) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Bimzelx is the first IL-17A and IL-17F inhibitor to be approved in the Americas.
Clinical studies involving the treatment of Bimzelx met their primary endpoints, resulting in significant improvement in the measures of disease activity compared to placebo, ustekinumab and adalimumab at Week 16. Significant improvements were also observed in psoriasis involving the scalp, nails, hands and feet in patients treated with Bimzelx at Week 16.
All phase III studies also met their ranked secondary endpoints: Patients treated with bimekizumab achieved superior levels of skin clearance at week 16, compared to those treated with ustekinumab, placebo and adalimumab, as measured by at least a 90 per cent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). Clinical responses achieved with bimekizumab at week 16 were maintained up to one year in all studies. Bimzelx was superior to placebo, ustekinumab and adalimumab in achieving PASI 75 at week 4.
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