Planned website maintenance is taking place from 11:00 pm AEDT on Friday 30 October to 6:00 am AEDT on Saturday 31 October 2026. Some pages may be temporarily unavailable. If issues continue outside this time, please contact us.
Spevigo
Published
Product name
Spevigo
Active ingredient
Spesolimab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Spevigo (spesolimab) was approved for the following therapeutic use:
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis.
How this medicine works
Spesolimab is a humanised antagonistic monoclonal immunoglobulin G1 (IgG1) antibody blocking human interleukin-36 receptor (IL36R) signalling. Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL36 α, β and γ) and downstream activation of pro inflammatory and pro-fibrotic pathways. IL36R signalling is differentiated from tumour necrosis factor alpha (TNF-α), integrin and interleukin-23 (IL-23) inhibitory pathways by directly and simultaneously blocking both inflammatory and pro-fibrotic pathways. Genetic human studies have established a strong link between IL36R signalling and skin inflammation.
Following treatment with Spevigo in patients with generalised pustular psoriasis (GPP), reduced levels of C-reactive protein (CRP), interleukin (IL)-6, T-helper cell (Th1/Th17) mediated cytokines, keratinocyte-mediated inflammation, neutrophilic mediators, and proinflammatory cytokines were observed in serum and skin at Week 1 compared to Baseline and was associated with a decrease in clinical severity. These reductions in biomarkers became more pronounced at the last measurement at Week 8 in Effisayil-1.
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 Spevigo was considered favourable for the therapeutic use approved.
Sponsor