perampanel
Neurology· 62 cited findings· 1 source document
Company: Eisai Co., Ltd. →
What the regulatory reviews say
Perampanel is an anti-epileptic drug. The International Birth Date for perampanel was 23 July 2012. Study E2007-M091-508, completed on 13 March 2020, enrolled 200 patients (32 adolescent patients <18 years old) with an overall median age of 24 years (age range 12 to 67 years).
In adolescent patients who completed the study, the median percent change from baseline in seizure frequency ranged from -90.11% to -100.00%. The 50% reduction (responder rate) in seizure frequency for adolescent patients was 96.15%. Seizure-free rates in adolescent patients ranged from 38.46% to 61.54%. For adolescent patients using the Last Observation Carried Forward (LOCF) method, the median percent change from baseline in seizure frequency ranged from -86.67% to -100.00%.
The safety analysis included 199 subjects, with 32 adolescent patients. The median duration of perampanel exposure was 175 days for the overall population and 173.5 days for adolescent patients. In the overall population, 36 patients reported non-serious adverse events (60 total events), with 46 Grade 1 (mild) and 14 Grade 2 (moderate) events. No Serious Adverse Events (SAEs) or Grade 3 (severe) adverse events were reported.
Key figures — cited to the source page
| Median percent change from baseline in seizure frequency (adolescent, completed study) | -100.00% | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.9 |
| 50% reduction (responder rate) in seizure frequency (adolescent, completed study) | 96.15% | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.9 |
| Seizure-free patients (adolescent, completed study) | 61.54% | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.9 |
| Patients in Safety Analysis Set | 199 | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.12 |
| Median duration of perampanel exposure (Overall Population) | 175 | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.12 |
| Patients reporting non-serious AEs (Overall Population) | 36 | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.13 |
| Serious Adverse Events (SAEs) | 0 | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.13 |
| International Birth Date | 23 July 2012 | Eisai Co., Ltd. — Fycompa EMA EPAR variation assessment repo, p.4 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.