Alfasigma S p A — Jyseleca EMA EPAR variation assessment report (EMEA/H/C/005113, 2020)
Alfasigma S p A · 2020 · EMA EPAR variation assessment report
Report summary
This report details the Type II variation application for Jyseleca (filgotinib) to extend its indication to active ulcerative colitis in adults. It covers non-clinical data, including pharmacology and toxicology, and extensive clinical trial data from the SELECTION study (GS-US-418-3898). The study demonstrated filgotinib's efficacy in achieving clinical remission in both biologic-naive and biologic-experienced patients during induction and maintenance phases. Safety analyses highlighted dose-dependent risks for adverse events, particularly herpes zoster, and a small numerical imbalance in cardiovascular deaths with the 200 mg dose. Despite these safety concerns, the CHMP concluded a positive benefit-risk profile for filgotinib 200 mg in moderately to severely active ulcerative colitis patients who had inadequate response to previous therapies, recommending approval for the extended indication.
Key findings — cited to the page
| TEAE with Grade 3 or Higher (Maintenance Placebo for Filgotinib 100 mg, Cohort 2) | 19.6 EAIR | · p.135 |
| TEAE with Grade 3 or Higher (Placebo, Cohort 3) | 24.9 EAER | · p.136 |
| TEAE with Grade 3 or Higher (Placebo, Cohort 1) | 56.0 EAIR | · p.134 |
| TEAE with Grade 3 or Higher (Maintenance Filgotinib 100 mg, Cohort 2) | 9.4 EAIR | · p.135 |
| TEAE with Grade 3 or Higher (Filgotinib 200 mg, Cohort 3) | 18.3 EAER | · p.136 |
| TEAE with Grade 3 or Higher (Filgotinib 100 mg, Cohort 3) | 28.9 EAER | · p.136 |
| TEAE with Grade 3 or Higher (Filgotinib 200 mg, Cohort 1) | 33.4 EAIR | · p.134 |
| TEAE with Grade 3 or Higher (Filgotinib 100 mg, Cohort 1) | 40.7 EAIR | · p.134 |
| TEAE with Grade 3 or Higher (Maintenance Filgotinib 200 mg, Cohort 2) | 10.8 EAIR | · p.135 |
| TEAE with Grade 3 or Higher (Maintenance Placebo for Filgotinib 200 mg, Cohort 2) | 13.0 EAIR | · p.135 |
| TEAE with Grade 3 or Higher (Maintenance Placebo, Cohort 2) | 13.5 EAIR | · p.135 |
| EAIR for grade 3 or 4 AST in filgotinib 200 mg | 0.6 /100 PYE | · p.160 |
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 →