Almirall S A — Ilumetri EMA EPAR public assessment report (EMEA/H/C/004514, 2018)
Almirall S A · 2018 · EMA EPAR public assessment report
Report summary
This report summarizes the EMA's assessment of Almirall S.A.'s Ilumetri (tildrakizumab) for moderate-to-severe plaque psoriasis, leading to a positive marketing authorization opinion in July 2018. The submission detailed tildrakizumab's mechanism as an IL-23 inhibitor, its robust manufacturing and quality control, and extensive non-clinical studies demonstrating its pharmacological activity and safety in cynomolgus monkeys. Clinical pharmacology, including PK/PD profiles, tolerability, and low immunogenicity, was thoroughly evaluated. Pivotal Phase 3 trials (P010, P011) consistently showed tildrakizumab's superiority over placebo and etanercept in achieving primary efficacy endpoints (PASI 75, PGA 'clear' or 'minimal'). The safety profile, analyzed across various studies, identified common adverse events like nasopharyngitis and injection site reactions, with overall good tolerability and no significant safety concerns.
Key findings — cited to the page
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 47.6 % | P011 · p.62 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 4.5 % | P011 · p.68 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 7.1 % | P010 · p.51 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 4.5 % | P011 · p.62 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 57.9 % | P010 · p.66 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 59.1 % | P010 · p.66 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 57.9 % | P010 · p.51 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 59.1 % | P010 · p.51 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 54.7 % | P011 · p.62 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 59.2 % | P011 · p.62 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 7.1 % | P010 · p.66 |
| PGA 'clear' or 'minimal' with at least 2-grade reduction | 54.7 % | P011 · p.68 |
Source: Almirall S A ↗ · 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 →