Alfasigma S p A — Jyseleca EMA EPAR public assessment report (EMEA/H/C/005113, 2020)
Alfasigma S p A · 2020 · EMA EPAR public assessment report
Report summary
The EMA Public Assessment Report for Jyseleca (filgotinib) details its regulatory submission for moderately to severely active rheumatoid arthritis. It covers comprehensive quality, non-clinical, and clinical data, including extensive toxicology studies highlighting male reproductive organ effects and immune suppression. Clinical trials (FINCH 1, 2, 3) demonstrated filgotinib's efficacy in improving ACR20, DAS28(CRP) remission, and preventing structural damage across various patient populations (MTX-IR, bDMARD-IR, MTX-naïve). The safety profile includes concerns like infections, herpes zoster, VTE, malignancies, and male infertility, leading to specific warnings, contraindications, and risk minimization measures. Dose adjustments for renal impairment are also outlined.
Key findings — cited to the page
| TEAE Related to Study Drug with Grade 3 or Higher (Filgotinib 100 mg) | 1.0% | · p.98 |
| TEAEs with Grade 3 or Higher in Filgotinib 200 mg QD + csDMARDs (eGFR 30-60) | 24.7 % | · p.131 |
| TEAE with Grade 3 or Higher (Total Filgotinib) | 3.8% | · p.98 |
| TEAE Related to Study Drug with Grade 3 or Higher (Filgotinib 200 mg) | 1.8% | · p.98 |
| TEAE Related to Study Drug with Grade 3 or Higher (Adalimumab) | 2.5% | · p.98 |
| TEAE Related to Study Drug with Grade 3 or Higher (Other) | 0.9% | · p.98 |
| TEAE with Grade 3 or Higher (Filgotinib 200 mg) | 3.8% | · p.98 |
| TEAE with Grade 3 or Higher (Filgotinib 100 mg) | 3.9% | · p.98 |
| TEAE with Grade 3 or Higher (Adalimumab) | 4.0% | · p.98 |
| TEAE with Grade 3 or Higher (Other) | 3.3% | · p.98 |
| TEAE Related to Study Drug with Grade 3 or Higher (Total Filgotinib) | 1.5% | · p.98 |
| TEAEs with Grade 3 or Higher in Filgotinib 200 mg QD Monotherapy (eGFR 30-60) | 15.0 % | · p.131 |
Source: Alfasigma S p 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 →