Fycompa

Neurology· 851 cited findings· 1 source document

What the regulatory reviews say

Fycompa (perampanel) is indicated for the treatment of partial-onset seizures. Regulatory review for Fycompa began with an eligibility agreement for centralized procedure on 26 October 2010, leading to a Marketing Authorisation application submission on 24 May 2011, and a positive opinion for Marketing Authorisation on 24 May 2012.

In clinical trials, perampanel demonstrated efficacy in reducing seizure frequency. For example, the median change in seizure frequency for perampanel 8 mg was -27.63% and for perampanel 12 mg was -36.91%, compared to a median change of -11.34% for placebo. The 50% responder rate for perampanel 8 mg was 37.6% versus 26.4% for placebo, and for perampanel 12 mg was 36.1% versus 26.4% for placebo. Another study showed a 50% responder rate of 40.5% for perampanel 8 mg and 40.0% for perampanel 12 mg, compared to 21.9% for placebo.

Safety findings included treatment-emergent adverse events (TEAEs) resulting in discontinuation, which were 19.0% in the 12 mg group and 9.3% in the 8 mg group. The need for dose reduction or interruption was 28.1% in the 12 mg group and 20.9% in the 8 mg group. Preclinical studies showed CNS depressant effects in rats at 5 mg/kg. The safety factor between preclinical hERG effect and the highest clinical plasma concentration was >100.

Key figures — cited to the source page

50% responder rate (perampanel 8 mg vs placebo)	37.6% vs 26.4%	Fycompa EMA EPAR public assessment report, p.52
50% responder rate (perampanel 12 mg vs placebo)	36.1% vs 26.4%	Fycompa EMA EPAR public assessment report, p.52
Median change in seizure frequency (perampanel 8 mg)	-27.63 %	Fycompa EMA EPAR public assessment report, p.53
Median change in seizure frequency (perampanel 12 mg)	-36.91 %	Fycompa EMA EPAR public assessment report, p.53
TEAEs resulting in discontinuation (12 mg group)	19.0 %	Fycompa EMA EPAR public assessment report, p.68
TEAEs resulting in discontinuation (8 mg group)	9.3 %	Fycompa EMA EPAR public assessment report, p.68
Positive opinion for Marketing Authorisation date	24 May 2012	Fycompa EMA EPAR public assessment report, p.6
Indication applied for	treatment of partial-onset seizures	Fycompa EMA EPAR public assessment report, p.4

Source documents

Eisai Co., Ltd. — Fycompa EMA EPAR public assessment report (EMEA/H/C/002434, 2012) (2012)

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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.