Galderma — Nemluvio EMA EPAR public assessment report (EMEA/H/C/006149, 2025)
Galderma · 2025 · EMA EPAR public assessment report
Report summary
Galderma International's Nemluvio (nemolizumab) received a positive EMA opinion on December 12, 2024, for marketing authorization. Indicated for moderate-to-severe atopic dermatitis and prurigo nodularis in patients aged 12 and older requiring systemic therapy, Nemluvio demonstrated significant efficacy. In atopic dermatitis, it showed superior IGA success and EASI-75 at Week 16 compared to placebo. For prurigo nodularis, Nemluvio significantly improved Peak Pruritus NRS and IGA success at Week 16. The drug, an IgG2 antibody, targets IL-31RA, inhibiting IL-31 activity. Manufacturing details, including a 3-year shelf life for the dual chamber syringe and 30 months for the autoinjector, are outlined. Non-clinical toxicology showed good tolerability. Clinical trials confirmed favorable pharmacokinetics and pharmacodynamics. Nemluvio was generally well-tolerated, with common adverse events including headache and eczematous reactions. Ongoing pharmacovigilance will monitor long-term safety.
Key findings — cited to the page
| IGA success (IGA 0 or 1 and >=2-grade improvement from baseline) | 11.0 % | Olympia 2 · p.293 |
| IGA success (IGA 0 or 1 and >=2-grade improvement from baseline) | 7.3 % | Olympia 1 · p.293 |
| IGA success (IGA 0 or 1 and >=2-grade improvement from baseline) | 26.3 % | Olympia 1 · p.293 |
| IGA success (IGA 0 or 1 and >=2-grade improvement from baseline) | 37.7 % | Olympia 2 · p.293 |
| Injection-Related Reactions (IRR) (%) | 0.5 % | · p.251 |
| Subjects experiencing IRR | 0.2 % | SPR.202699 - phase 3 LTE study · p.266 |
| Participants considering DCS instructional resources clear and effective as is | 65 participants | Nemolizumab Dual-Chamber Syringe · p.181 |
| Subjects experiencing IRR | 1 n | SPR.202699 - phase 3 LTE study · p.266 |
| Increase in IL-31 and IL-31R expression in PN lesions | 50-fold | · p.16 |
| Recommended dosage for Prurigo Nodularis (≥ 90 kg) | initial dose of 60 mg, followed by 60 mg every 4 weeks | Nemluvio · p.18 |
| Clinical program regions | North America (Canada and the US), Europe (Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Georgia, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Spain), United Kingdom, and Asia-Pacific (Australia, Korea, New Zealand, Singapore) | Nemolizumab · Global · p.19 |
| Active substance amount in finished product | 30 mg | Nemluvio · p.19 |
Source: Galderma ↗ · 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 →