Eisai's Supplementary New Drug Application Submitted In Japan for Fycompa.
TOKYO, Jan 30, 2019 - (JCN Newswire) - Eisai Co., Ltd. has filed a supplementary new drug application in Japan for its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) seeking approval for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.
The submission covering monotherapy for partial-onset seizures was based on the results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea. In FREEDOM, the percentage of untreated patients from 12 to 74 years of age with partial onset seizures who achieved seizure freedom with Fycompa monotherapy exceeded the criteria for efficacy, and the primary endpoint was met. The most common adverse events (incidence of 10% or higher) observed in this study were dizziness, somnolence, nasopharyngitis and headache, which is consistent with the safety profile of Fycompa to date.
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 in pediatric patients conducted in Japan, the United States and Europe. In Study 311 which evaluated Fycompa in pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures, it was demonstrated that the safety and efficacy of Fycompa in pediatric patients was similar to that observed in patients 12 years of age and older.
In addition, regarding the additional application for the fine granule formulation, Eisai developed this formulation to make it easier to administer Fycompa to children and patients who have difficulty taking tablets, and subsequently conducted a clinical study verifying bioequivalence with the tablet formulation, which led to this application.
Detailed results of FREEDOM and Study 311 will be presented at upcoming academic conferences.
Discovered at Eisai's Tsukuba Research Laboratories, Fycompa is a first-in-class AED that is a highly selective, noncompetitive AMPA receptor antagonist which reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Available in tablet form to be taken orally once daily, Fycompa is approved in Japan as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs.
It is estimated that there are approximately 1 million patients with epilepsy in Japan, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly.
Eisai considers neurology including epilepsy, a therapeutic area of focus, and in continued pursuit of our mission to provide "seizure freedom" to a greater number of patients living with epilepsy. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
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 Oncology and Neurology.
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 www.eisai.com.
Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120
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|Date:||Jan 30, 2019|
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