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.

"Improving seizure control is one of the most pressing unmet needs in epilepsy patients. Perampanel will be a completely new option for the adjunctive treatment of patients with uncontrolled seizures," noted Professor Bernhard Steinhoff, Professor of Neurology, Medical Director and Executive, Epilepsy Center, Kehl-Kork, Germany. "The positive opinion announced today by the CHMP is a significant step in ensuring patients have access to this first-in-class treatment in Europe."

The CHMP based its decision on clinical data from three pivotal Phase III, global, randomised, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients. Each of the studies showed consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in patients with partial-onset seizures (with or without secondary generalisations). Perampanel delivers the benefit of once-daily dosing, thereby helping to reduce the potential pill-burden a person with epilepsy may experience. The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls, and ataxia.

The development of perampanel and zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.

Source:

Eisai

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