Eisai: Approval of Antiepileptic Drug Fycompa in Japan for Monotherapy and Pediatric Indications for Partial-Onset Seizures, as well as a New Formulation
- Written by ACN Newswire - Press Releases
The approval for monotherapy for partial-onset seizures is based on the results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea. The outcome achieved the primary endpoint, with the rate of complete seizures-free exceeding the initially established efficacy criteria* in monotherapy for untreated epilepsy patients aged 12 to 74 years with partial-onset seizures. The most common adverse events (incidence of 10% or higher) observed in this study were dizziness, somnolence, nasopharyngitis, and headache, which were consistent with the safety profile of Fycompa to date.
The additional approval covering partial-onset seizures in pediatric epileptic patients 4 years of age and older is 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. This study showed that the safety and efficacy of Fycompa combination therapy in pediatric epilepsy patients with poorly controlled partial seizures (ages 4 to less than 12 years) were similar to those in patients aged 12 years and older.
The additional approval for the fine granule formulation is based on the results of a bioequivalence study of fine granules and tablets conducted in Japan. Eisai developed this formulation to make it easier to administer Fycompa to children and patients who have difficulty taking tablets. The study confirmed the bioequivalence of fine granules and tablets.
Fycompa is a first-in-class AED and a once-daily oral drug discovered at Eisai's Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Fycompa has been approved in many countries around the worldwide as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older and as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In the United States, Fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.
The number of epilepsy patients in Japan is estimated to be approximately 1 million, and it is possible that the disease may occur regardless of age group, but it is said that the incidence is particularly high in children and the elderly. Eisai considers neurology including epilepsy as a priority disease area, and provides information on the appropriate use of Fycompa, aiming to satisfy the diverse needs of patients and their families and offer improved benefits. With the approval for monotherapy, pediatric indication aged 4 years and older and fine granule formulation, Eisai will continue to prioritize the provision of safety information. Furthermore, Eisai will pursue its mission of delivering "seizure freedom" to as many patients as possible.
*The criteria for efficacy in this study with 73 patients for evaluation of efficacy required a 52.1% or higher proportion of patients to have achieved seizure freedom, which was set primarily in consideration of the results from other AED monotherapy studies.
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 in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.
In its medium-term business plan EWAY2025, Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.
For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.
Contact:Public Relations Department Eisai Co., Ltd. +81-(0)3-3817-5120
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Authors: ACN Newswire - Press Releases
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