Eisai Announces Launch of Antiepileptic Drug Fycompa in U.S.
Tokyo, Jan 6, 2014 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo,
President & CEO: Haruo Naito, "Eisai") announced today that on
January 2, 2014, its U.S. subsidiary Eisai Inc. launched the AMPA receptor
antagonist Fycompa (perampanel), a first-in-class antiepileptic drug (AED)
discovered and developed In-house, in the United States as an adjunctive
therapy for partial-onset seizures with or without secondary generalized
seizures in patients with epilepsy aged 12 and older.
Fycompa is a highly selective, noncompetitive AMPA receptor antagonist
discovered and developed by Eisai. With epileptic seizures being primarily
mediated by the neurotransmitter glutamate, the agent works as a first-in-class
AED that reduces neuronal hyperexcitation associated with seizures by targeting
glutamate activity at postsynaptic AMPA receptors. It is approved in more than
35 countries worldwide,
mostly in Europe and North America, and has been already launched in Canada
and in a number of European countries. In the United States, following approval
by the U.S. Food and Drug Administration (FDA) in October 2012, Fycompa was
recommended to the U.S. Drug Enforcement Administration (DEA) for scheduling
classification under the country's Controlled Substances Act and
subsequently placed as a
Schedule III drug. The number of patients with epilepsy in the United States
is approximately 2.2 million people and approximately 150,000 people are
estimated to be newly diagnosed with epilepsy in that country each year.
Furthermore, some 60% of patients diagnosed with epilepsy in the United States
have partial seizures, of which approximately 25% to 30% are unable to control
their seizures with current treatment options. Fycompa, which has a mechanism
of action different to that of other licensed AEDs, offers a new treatment
option for epilepsy patients with partial-onset seizures. Indicated for a wide
range of patients, including adults and adolescents over 12 years of age, the
agent has the added benefit of once-daily oral dosing, which is expected to
reduce the potential pill-burden a patient with epilepsy may experience as well
as improve patient drug compliance.
Eisai defines epilepsy as a therapeutic area of focus and in the United States
markets Zonegran (under license from the originator Dainippon Sumitomo Pharma
Co., Ltd.) as a treatment for partial-onset epilepsy in adults and BANZEL
(under license from the originator Novartis AG) as a treatment for
Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy. By
treatment options as part of an extensive epilepsy product portfolio, Eisai
seeks to make continued contributions to addressing the diverse needs of, as
well as increasing the benefits provided to, patients with epilepsy and their
For further information on epilepsy, Fycompa,the Phase III studies and
Eisai's commitment to epilepsy, visit
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department,
Eisai Co., Ltd.
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