We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Bimzelx
Published
Product name
Bimzelx
Active ingredient
Bimekizumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Bimzelx (bimekizumab) was approved for the following therapeutic use:
Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
How this medicine works
Bimekizumab is a humanised immunoglobulin G1 kappa (IgG1/κ) monoclonal antibody. It has two identical antigen binding regions that bind and neutralise interleukin (IL) 17A, IL 17F and IL 17AF cytokines. Levels of IL 17A and IL 17F are elevated in several immune mediated inflammatory diseases and drive chronic inflammation and damage across multiple tissues. In human in vitro disease models, dual neutralisation of both IL 17A and IL 17F with bimekizumab suppresses the expression of inflammation related genes and proteins to a greater extent than inhibition of IL 17A alone.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Bimzelx was considered favourable for the therapeutic use approved.