China Approves Anti-epileptic Monotherapy For Partial-onset Seizures

Eisai Co., Ltd. has developed an anti-epileptic drug (AED) Fycompa (generic name: perampanel) which obtained two additional approvals as "a monotherapy for partial-onset seizures" and "an adjunctive treatment / a monotherapy for pediatric indication for partial onset seizures in patients with epilepsy 4 years of age and older" in China from the National Medical Products Administration.Fycompa has already been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. Through this approval, Fycompa is now available in China as a monotherapy and an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs1, this is a disease with significant unmet medical needs.Fycompa is a first-in-class AED and a once-daily tablet discovered at Eisai's Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.Eisai considers neurology, including epilepsy, a therapeutic area of focus. With this approval for Fycompa as a monotherapy and pediatric indication for patients with epilepsy 4 years or older in China, Eisai will continue to prioritize the provision of safety information, and pursue its mission to provide "seizure freedom" to a greater number of patients with epilepsy across the world. Eisai seeks to address the diverse needs of, as well as increase the benefits provided to, patients with epilepsy and their families.

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