EMA CHMP issues positive opinion to Eisai’s Fycompa for treatment of partial-onset seizures

Published on May 29, 2012 at 3:14 AM · No Comments

Eisai announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Fycompa® (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.    

Perampanel has a different mechanism of action to current antiepileptic drugs (AEDs). As an AMPA receptor antagonist, perampanel is the first of a new class of AED. The neurotransmitter glutamate plays a major role in the mediating seizures and perampanel is the only agent that selectively targets the transmission of seizures by blocking post synaptic glutamate AMPA receptors. AMPA receptors are currently not selectively targeted by any other available AED. Based on today's recommendation, EU approval of the new therapy is anticipated within three months.

In addition to the CHMP recommendation for the use of perampanel as an adjunctive treatment, Eisai received a positive CHMP opinion for Zonegran® (zonisamide) as monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. Zonisamide is a second generation AED with multiple mechanisms of action and a chemical structure which is unrelated to any other AED.

The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some patients. The incidence of uncontrolled epilepsy remains high despite many new AEDs and between 20 - 40% of patients with newly diagnosed epilepsy will become refractory to treatment.

Perampanel is a completely new option for the management of partial onset epilepsy as it is the first AED to exhibit clinical efficacy against partial-onset seizures by selectively (non-competitively) blocking AMPA receptor-mediated excitatory neurotransmission.

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment