CHMP recommends approval of Fycompa (Eisai) for Epilepsy - 28-May-2012

The CHMP has issued a positive opinion for the use of Fycompa (perampanel), from Eisai, as an adjunctive treatment of focal seizures, with or without secondarily generalised seizures, in patients with Epilepsy aged 12 years and older. Fycompa is a new option for the management of partial onset Epilepsy as it is the first AED to exhibit clinical efficacy against focal seizures by selectively (non-competitively) blocking AMPA receptor-mediated excitatory neurotransmission. The CHMP based its decision on clinical data from three pivotal Phase III studies in 1,480 Epilepsy patients. Each of the studies showed consistent results in the efficacy and tolerability of Fycompa as an adjunctive therapy in patients with focal seizures (with or without secondary generalisations). The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls, and ataxia. Based on the recommendation, EU approval of the new therapy is anticipated within three months.