LEO A S — Kyntheum EMA EPAR public assessment report (EMEA/H/C/003959, 2017)
LEO A S · 2017 · EMA EPAR public assessment report
Report summary
The EMA granted marketing authorization for Kyntheum (brodalumab) for moderate to severe plaque psoriasis, based on a positive benefit-risk assessment. Brodalumab, a human monoclonal IgG2 antibody, targets IL-17RA, demonstrating consistent receptor occupancy and dose-dependent inhibition of IL-17 signaling. Clinical trials showed superior efficacy, particularly with the 210 mg Q2W dose, compared to placebo and ustekinumab, with rapid and significant improvements in PASI and sPGA scores. While generally well-tolerated, potential risks include infections, neutropenia, and suicidal ideation/behavior (SIB), which will be further monitored post-authorization. The CHMP concluded that Kyntheum's efficacy outweighs its identified and potential risks.
Key findings — cited to the page
| Grade 3 decreases in ANC | 0.4 % | · p.110 |
| Grade 2 decreases in ANC | 2.2 % | · p.110 |
| Grade 2 decreases in ANC | 1.1 % | · p.110 |
| IC50 for IL-6 production induced by IL-17F (human dermal fibroblasts) | 0.29-2.46 ng/ml | Brodalumab · p.17 |
| Grade 1 decreases in ANC | 7.8 % | · p.110 |
| Grade 1 decreases in ANC | 5.5 % | · p.110 |
| Inhibition of IL-17C- plus TNFα-induced beta-defensin 2 gene production | 40 % | Brodalumab · p.17 |
| IC50 for IL-6 production induced by IL-17F (monkey dermal fibroblasts) | 0.83-54 ng/ml | Brodalumab · p.17 |
| IC50 for IL-6 production induced by IL-17A (human dermal fibroblasts) | 33-143 ng/ml | Brodalumab · p.17 |
| IC50 for IL-6 production induced by IL-17A (monkey dermal fibroblasts) | 33-383 ng/ml | Brodalumab · p.17 |
| IC50 for IL-6 production from rabbit dermal fibroblasts | 2670 ng/ml | Brodalumab · p.17 |
| Grade 3 decreases in ANC | 0.2 % | · p.110 |
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 →