Eisai has submitted a Marketing Authorization Application to the European Commission for its first-in-class anti-epileptic drug (AED) Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Perampanel is currently indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older. Generalized tonic-clonic seizures are one of the most dangerous types of seizure. The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.
The filing in this new indication is based on data from Study 332, a double-blind, randomized, placebo-controlled, multicenter, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory PGTC seizures. 164 people (>12 years old) with PGTC seizures, despite treatment with one to three concomitant AEDs were randomized to receive perampanel or placebo in a 1:1 ratio. Results demonstrate that perampanel significantly reduces PGTC seizure frequency and improved responder rates (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study’s two primary outcome measures, when compared to placebo.
The most frequent adverse events (10% in the perampanel arm and greater than placebo) are dizziness, fatigue and headache, irritability and somnolence. The adverse event profile is similar to that for other perampanel studies.
“Tonic-clonic seizures are very serious and can have a profound effect on quality of life for people with epilepsy. We believe that perampanel has great potential in this area and have filed in Europe for a license extension to include the adjunctive treatment of PGTC seizures in people with epilepsy,” commented Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.
Perampanel is the only licensed AED to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to all other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on July 23, 2012. Perampanel has been approved in more than 35 countries.
Date: August 20, 2014
Source: Eisai
Filed Under: Drug Discovery
