Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment report (EMEA/H/C/002434, 2012)
Eisai Co., Ltd. · 2012 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the European Medicines Agency's assessment of Eisai Co., Ltd.'s paediatric studies for Fycompa (perampanel). The primary focus was the Phase 4, open-label study E2007-M091-508 conducted in India, evaluating perampanel as adjunctive therapy for partial-onset seizures in patients aged 12 and older. The assessment specifically analyzed the adolescent subgroup (12-17 years), presenting efficacy data (seizure frequency reduction, responder rates) and safety findings, including adverse events like cough and paraesthesia. The report concluded that no new safety concerns were identified for paediatric use, and initial issues regarding patient inclusion criteria were resolved.
Key findings — cited to the page
| Grade 1 (mild) AEs reported | 46 events | Study E2007-M091-508 · p.13 |
| Grade 2 (moderate) AEs reported | 14 events | Study E2007-M091-508 · p.13 |
| Grade 3 (severe) AEs reported | 0 | Study E2007-M091-508 · p.13 |
| International Birth Date | 23 July 2012 | Fycompa (perampanel) · EU · p.4 |
| Enrolled patients | 200 patients | Study E2007 -M091-508 · India · p.4 |
| Enrolled adolescent patients (<18 years) | 32 patients | Study E2007 -M091-508 · India · p.4 |
| Planned enrollment | 200 patients | Study E2007 -M091-508 · India · p.4 |
| Treatment period duration | 6 months | Study E2007-M091-508 · p.5 |
| Study sites | 12 | Study E2007-M091-508 · India · p.5 |
| Patients screened and enrolled (Overall Population) | 200 patients | Study E2007-M091-508 · p.8 |
| Patients screened and enrolled (Adolescent Population) | 32 patients | Study E2007-M091-508 · p.8 |
| Study phase | Phase 4 | Study E2007 -M091-508 · p.4 |
Source: Eisai Co., Ltd. ↗ · 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 Neurology library →