Fycompa® Approved in China as Adjunctive Therapy for Primary Generalized Tonic-Clonic Seizures

Eisai announced today that it has received approval in China for an additional indication of its antiepileptic drug (AED) Fycompa® (generic name: perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients aged 12 years and older.

Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. It is a selective, noncompetitive AMPA receptor antagonist that is believed to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.

In China, Fycompa was initially approved in September 2019 for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients aged 12 years and older. Since its launch in January 2020, it has also received approval in July 2021 for additional indications, including monotherapy and adjunctive use in treating partial-onset seizures in patients aged 4 years and older, thereby broadening its impact on epilepsy patients in China.

China has an estimated 9 million patients with epilepsy. Approximately 30%-40% of these patients are unable to control their seizures with currently available AEDs. Primary generalized tonic-clonic seizures, one of the most severe forms of epileptic seizures, can cause significant injury and are a leading risk factor for sudden unexpected death in epilepsy (SUDEP). With this new indication, Fycompa can now be used in China as an adjunctive treatment for primary generalized tonic-clonic seizures.

Eisai considers neurology, including epilepsy, a key therapeutic area. As a company dedicated to human health care, Eisai is committed to its mission of providing “seizure freedom” to a greater number of epilepsy patients. Eisai remains dedicated to meeting the diverse needs of patients with epilepsy and their families, enhancing their quality of life.

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