TOKYO, Aug 2, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that its in-house discovered and developed anti-epileptic drug (AED) Fycompa (generic name: perampanel) has 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.
The approval covering monotherapy for partial-onset seizures was based on subgroup analysis estimating monotherapy safety and efficacy within clinical studies of Fycompa as adjunctive therapy (Study 304, 305, 306, and 335) conducted globally including the United States, Europe and China on patients ages 12 years and older with partial-onset seizures (with or without secondarily generalized seizures). Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data of Fycompa as monotherapy.
The approval covering partial-onset seizures in pediatric patients was based on the results of a Phase III clinical study (Study 311) of Fycompa as adjunctive therapy conducted globally on pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
In China, it is estimated that there are approximately 9 million patients with epilepsy, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. 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.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
For more information, visit https://www.eisai.com/news/2021/news202166.html.
Source: Eisai
Copyright 2021 JCN Newswire . All rights reserved.
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.
The approval covering monotherapy for partial-onset seizures was based on subgroup analysis estimating monotherapy safety and efficacy within clinical studies of Fycompa as adjunctive therapy (Study 304, 305, 306, and 335) conducted globally including the United States, Europe and China on patients ages 12 years and older with partial-onset seizures (with or without secondarily generalized seizures). Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data of Fycompa as monotherapy.
The approval covering partial-onset seizures in pediatric patients was based on the results of a Phase III clinical study (Study 311) of Fycompa as adjunctive therapy conducted globally on pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
In China, it is estimated that there are approximately 9 million patients with epilepsy, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. 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.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
For more information, visit https://www.eisai.com/news/2021/news202166.html.
Source: Eisai
Copyright 2021 JCN Newswire . All rights reserved.
