Eisai's Antiepileptic Drug Fycompa® Gains Approval in China for Additional Indication

14 May 2024 | Tuesday | News

Fycompa® Now Approved for Adjunctive Treatment of Primary Generalized Tonic-Clonic Seizures in Patients Aged 12 and Older, Expanding Options for Epilepsy Care
Image Source : Public Domain

Image Source : Public Domain

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

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

In China, Fycompa was approved for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy aged 12 years and older in September 2019.

Since its launch in January 2020, it has received approval in July 2021 for the additional indications for monotherapy and adjunctive use in the treatment of partial-onset seizures in patients with epilepsy aged 4 years and older, thereby expanding its contribution to epilepsy patients in China.

In China, it is estimated that there are approximately 9 million patients with epilepsy.(1) As 30%-40% of patients with epilepsy are unable to control their seizures with currently available AEDs.(2) As one of the most severe forms of epileptic seizures, primary generalized tonic-clonic seizures can cause significant injury to patients and are one of the leading risk factors associated with sudden unexpected death in epilepsy (SUDEP). Through this indication expansion, Fycompa can now be used in China as an adjunctive treatment for primary generalized tonic-clonic seizures.

Eisai considers neurology, including epilepsy, a therapeutic area of focus. As a human health care company, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai remains committed to further addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

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