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Spevigo
Spevigo (spesolimab) was approved for the following therapeutic use:
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis.
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.
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.