Almirall S A — Skilarence EMA EPAR public assessment report (EMEA/H/C/002157, 2017)
Almirall S A · 2017 · EMA EPAR public assessment report
Report summary
The EMA granted marketing authorization for Almirall S.A.'s Skilarence (dimethyl fumarate) for moderate to severe plaque psoriasis in 2017. The application, based on company studies and existing literature, confirmed the drug's pharmaceutical quality, manufacturing, and non-clinical safety, including similar toxicological profiles for DMF alone versus DMF/MEF combinations. Clinical development, including a pivotal Phase III study (1102), demonstrated Skilarence's superiority over placebo and non-inferiority to Fumaderm in achieving PASI 75 and PGA clear/almost clear responses. While the exact mechanism is unclear, immunomodulatory effects are noted. Common adverse events include gastrointestinal issues, flushing, and lymphopenia, consistent with other DMF products. Reproductive toxicity led to pregnancy contraindications. Long-term efficacy and rare adverse events require further post-authorization studies.
Key findings — cited to the page
| Marketing Authorisation Application submission date | 2 December 2015 | Skilarence · EU · p.6 |
| Indication | treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy | Skilarence · p.6 |
| Legal basis for application | Article 8(3) of Directive 2001/83/EC - complete and independent application | Skilarence · p.6 |
| Scientific Advice from CHMP dates | 17 February 2011, 21 November 2013 | Skilarence · p.6 |
| Non-inferiority margin for PASI 75 | 15 % | Skilarence · p.11 |
| DMF starting dose in Phase III clinical trial | 30 mg daily | · p.17 |
| DMF maximum dose in Phase III clinical trial | 720 mg daily | · p.17 |
| NOAEL for DMF and DMF + MEF salts in 13-week dog toxicity study | 30 mg/kg/day | · p.20 |
| DMF exposure margin (Cmax) in males and females combined (MMF) compared to human exposure (720 mg total dose) | 6.53 | · p.20 |
| DMF exposure margin (AUC0-24) in males and females combined (MMF) compared to human exposure (720 mg total dose) | 2.91 | · p.20 |
| DMF + MEF salts exposure margin (Cmax) compared to human exposure (720 mg total dose) | 9.7 | · p.20 |
| CHMP positive opinion date | 18-21 April 2017 | Skilarence · EU · p.7 |
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 →