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
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.