Eisai Co., Ltd. โ Fycompa EMA EPAR public assessment report (EMEA/H/C/002434, 2012)
Eisai Co., Ltd. ยท 2012 ยท EMA EPAR public assessment report ยท company profile โ
Report summary
Eisai Europe Ltd. submitted Fycompa (perampanel), a non-competitive AMPA glutamate receptor antagonist, to the EMA in May 2011 for partial-onset seizures. Approved in May 2012, the drug's non-clinical profile showed pharmacology-based CNS effects at high doses and potential reproductive toxicity, but no genotoxicity or carcinogenicity. Clinical trials (Studies 304, 305, 306) demonstrated dose-dependent efficacy as adjunctive therapy, with significant improvements in seizure frequency at 8mg and 12mg doses, despite Study 304 not reaching overall statistical significance. Common adverse events included dizziness, somnolence, and psychiatric disorders, with the 12mg dose showing increased adverse events but also improved efficacy in some patients. The CHMP concluded a favorable benefit-risk balance for patients aged 12 and older, recommending marketing authorization.
Key findings โ cited to the page
| NOEC for Daphnia sp. Reproduction Test | 220 ยตg/L | ยท p.18 |
| Irritability incidence (Study 231) | 10.0 % | Study 231 ยท p.97 |
| Irritability incidence (Study 231, adverse drug reactions) | 10.0 % | Study 231 ยท p.97 |
| Free drug concentration in clinical use (adjusted for protein binding) | 36 ng/mL | ยท p.12 |
| Procedure start date | 22 June 2011 | Fycompa ยท Europe ยท p.5 |
| Highest plasma concentration of Perampanel in clinical use | 799 ng/mL | ยท p.12 |
| hERG activity (IC50) | 5.52 ฮผg/mL | ยท p.12 |
| Anticonvulsant activity in murine audiogenic seizure model (ED50) | 0.47 mg/kg | ยท p.11 |
| Anticonvulsant activity in maximal electroshock seizure model (ED50) | 0.1.6 mg/kg | ยท p.11 |
| Protection from myoclonic seizures in pentylenetetrazol-induced seizure model (ED50) | 0.94 mg/kg | ยท p.12 |
| Afterdischarge threshold elevation in rats kindling model | 10 mg/kg | ยท p.12 |
| Positive opinion for Marketing Authorisation date | 24 May 2012 | Fycompa ยท Europe ยท p.6 |
Source: Eisai Co., Ltd. โ ยท License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only โ not investment advice. Explore the Neurology library โ