Eisai: Supplementary New Drug Applications for Anti-Epileptic Drug Fycompa as Monotherapy for Partial-Onset 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.

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Provider: 
JCN NewswireJCN Newswire
Retrieved on: 
Friday, October 16, 2020
Information
Tags: 
Neurological disorders, Health, Clinical medicine, Anticonvulsants, RTT, Epilepsy, Seizure types, Syndromes, Generalized tonic–clonic seizure, Epileptic seizure, Generalized epilepsy, Perampanel
Organisation: 
EISAI
Summary
Key Points: 
  • 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.
  • The submission 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.
  • 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 has 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.




Pediatric Indication for Partial-Onset Seizures Accepted in China


TOKYO, Oct 16, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that the supplementary new drug applications for its in-house discovered and developed anti-epileptic drug (AED) Fycompa (generic name: perampanel) as monotherapy for partial-onset seizures and pediatric indication for partial onset seizures in patients with epilepsy 4 years or older have been accepted in China by the National Medical Products Administration.

The submission covering monotherapy for partial-onset seizures was based on subgroup analysis estimating monotherapy safety and efficacy within clinical studies of the combination 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.

The submission 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. Fycompa has 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.

Eisai considers neurology, including epilepsy, a therapeutic area of focus. With the acceptance of these additional applications regarding Fycompa in China, Eisai pursues 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 increasing the benefits provided to, patients with epilepsy and their families.

For more information, visit https://www.eisai.com/news/2020/pdf/enews202064pdf.pdf.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit https://www.eisai.com

Source: Eisai

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