Eisai Co.,?Ltd.?(Headquarters: Tokyo, CEO: Haruo Naito,?“Eisai”)?announced today thatEisai received?a?New Drug Approval for?its in-house?discovered?and?developed?antiepileptic drug (AED)?Fycompa??(perampanel)?from the China National Medical Products Administration (NMPA) for use in?an adjunctive?treatment?of?partial onset seizures?(with or without secondarily generalized seizures)in epilepsy patients?12 years of age and older.?Fycompa?was?designated for Priority Review by?the?NMPA?due to?itssignificant?clinical benefits?compared to existing treatments,?and?was?approved in about 12?months since?the?submission in?September?2018.

In China, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60%?of whom?being affected by?partial-onset seizures.?About?40%?patients with partial-onset seizures?require?adjunctive treatment.¹As approximately30% of patients with epilepsy are unable to control their seizures?with currently available AEDs,?²this is a disease with significant unmet medical needs.

Fycompa?is a first-in-class AED discovered at Eisai¡¯s Tsukuba Research Laboratories. Administered orally?once-daily, it is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal?hyperexcitation?associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic?membranes.

Fycompa?has been approved in over?60?countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in?patients with?epilepsy?12 years of age?and older. In addition,?Fycompa?has been approved in over 55?countries as an adjunctive treatment for?primary generalized tonic-clonic seizures in patients?with epilepsy?12 years of age and older. In?the United?States,?Fycompa?is also indicated for monotherapy and adjunctive use in the treatment of partial-onset?seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

Eisai considers neurology including epilepsy, a therapeutic area of focus. With this approval of Fycompa?in China, Eisai?pursues our mission to provide?“seizure freedom”?to a greater number of patients?with?epilepsy?across the world?living. Eisai?seeks to address the diverse needs of, as well as increasing the?benefits provided to, patients with epilepsy and their families.

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Eisai Co., Ltd.
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