LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/C/005874, 2022)
LEO A S · 2022 · EMA EPAR public assessment report
Report summary
The EMA assessed Spevigo (spesolimab) for generalized pustular psoriasis (GPP) flares, granting conditional marketing authorization due to its positive benefit-risk balance and addressing an unmet medical need. Spevigo, an IL-36R blocker, demonstrated significant pustular clearance at week 1 in the pivotal trial 1368-0013. While overall adverse events were comparable to placebo, infections were more frequent with spesolimab. Non-clinical and clinical studies confirmed its mechanism, pharmacokinetics, and safety profile. Long-term efficacy and safety data, especially for recurrent flares, are limited, necessitating post-authorization studies. The CHMP did not grant accelerated assessment but recognized spesolimab as the first targeted therapy for GPP.
Key findings — cited to the page
| Patients with severe AEs (RCTC grade 3) in spesolimab group (Week 1) | 17.1 % | 1368-0013 · p.128 |
| Patients with severe AEs (RCTC grade 3) in placebo group (Week 1) | 11.1 % | 1368-0013 · p.128 |
| IC90-values of BI674304 to inhibit mouse IL36α, β or γ-induced IL-2 and IFNγ cytokine production or NFκB phosphorylation | 0.57-2.68 µg/mL | · p.32 |
| IC90-values of BI674304 to inhibit mouse IL36α, β or γ-induced IL-2 and IFNγ cytokine production or NFκB phosphorylation | 0.57-2.68 µg/mL | · p.35 |
| IC90-values of BI674304 to inhibit mouse IL36α, β or γ-induced IL-2 and IFNγ cytokine production or NFκB phosphorylation | 3.8-18 nM | · p.32 |
| IC90-values of BI674304 to inhibit mouse IL36α, β or γ-induced IL-2 and IFNγ cytokine production or NFκB phosphorylation | 3.8-18 nM | · p.35 |
| All-cause mortality for hospitalized GPP flare patients | 2.5 % | · p.11 |
| GPP mean age of onset | 41 years | · p.10 |
| GPP prevalence | 0.2 to 0.3 per 10 000 persons | Japan · p.10 |
| GPP patients reporting severe flares | 76 % | · p.11 |
| GPP patients visiting emergency department due to flare | 23 % | · p.11 |
| GPP patients experiencing >=4 flares in previous year | 46 % | · p.11 |
Source: LEO A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →