Fycompa®, an antiepileptic drug 13 May, has gained approval in China as an adjunctive therapy for primary generalized tonic-clonic seizures.
Fycompa® Eisai Co., Ltd
Fycompa® antiepileptic drug Eisai Co., Ltd., headquartered in Tokyo and led by CEO Haruo Naito, has announced the approval of an expanded indication for its internally developed antiepileptic drug (AED) Fycompa® in China. This approval covers the adjunctive treatment of primary generalized tonic-clonic seizures in epilepsy patients aged 12 years and older.
Fycompa, a pioneering AED originating from Eisai’s Tsukuba Research Laboratories, acts as a selective, noncompetitive AMPA receptor antagonist. It functions by potentially reducing neuronal hyper-excitation associated with seizures through its targeting of glutamate activity at AMPA receptors on postsynaptic membranes.
Previously, in September 2019, Fycompa received approval in China for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in epilepsy patients aged 12 years and older. Subsequent approvals followed, including in July 2021, expanding its indications to include monotherapy and adjunctive use for treating partial-onset seizures in epilepsy patients aged 4 years and older. This progression signifies an enhanced therapeutic option for epilepsy patients in China.
In China, there are an estimated 9 million individuals living with epilepsy. With current anti-epileptic drugs (AEDs), 30%-40% of these patients struggle to manage their seizures effectively. Primary generalized tonic-clonic seizures are among the most severe forms of epilepsy, posing a significant risk of injury and contributing to sudden unexpected death in epilepsy (SUDEP). Fycompa’s recent approval for adjunctive treatment of primary generalized tonic-clonic seizures in China marks a significant expansion in its indications.
Eisai prioritizes neurology, particularly epilepsy, as a key focus area. As a healthcare company dedicated to improving human health, Eisai is committed to advancing its mission of providing “seizure freedom” to a wider population of epilepsy patients. Eisai remains steadfast in its efforts to address the diverse needs of individuals with epilepsy and their families while enhancing the benefits they receive.
About (generic name: perampanel hydrate) Fycompa®
Fycompa, also known by its generic name perampanel hydrate, stands as a pioneering anti-epileptic medication pioneered and brought forth by Eisai. Its mechanism revolves around targeting the neurotransmitter glutamate, which plays a crucial role in epileptic seizures. Acting as a highly selective, noncompetitive AMPA receptor antagonist, it effectively mitigates neuronal hyperexcitation linked with seizures by modulating glutamate activity specifically at AMPA receptors situated on postsynaptic membranes.
This groundbreaking medication has garnered approval in over 75 countries and territories, spanning regions like Japan, China, Europe, and parts of Asia. Its primary endorsement lies in its role as an adjunctive therapy for partial-onset seizures, both with and without secondarily generalized seizures, in patients aged 12 and above. Furthermore, it has received clearance in these regions for its adjunctive use in treating primary generalized tonic-clonic seizures in the same age group.
Expanding its reach, Fycompa has attained approval for broader age ranges and expanded indications in different regions. In Japan and China, it has been sanctioned for both monotherapy and adjunctive use in treating partial-onset seizures, extending its utility to patients as young as 4 years old. In Europe, the approval extends to children as young as 4 years old for adjunctive therapy in partial-onset seizures and 7 years old for primary generalized tonic-clonic seizures.
Various formulations of Fycompa have been developed and approved, tailored to diverse patient needs and preferences. In Japan, a tablet, fine granule formulation, and injection formulation have received approval. Meanwhile, in Europe and China, an oral suspension formulation and tablet are available.
A notable development in the trajectory of Fycompa occurred in January 2023, when the commercial rights for the United States market were transferred to Catalyst Pharmaceuticals, Inc., indicating a strategic shift in its distribution and marketing approach.
Epilepsy Fycompa®
Epilepsy presents a broad spectrum of seizure types, with partial-onset seizures constituting roughly 60% of cases and generalized seizures making up the remaining 40%. During a partial-onset seizure, abnormal electrical activity occurs in a specific area of the brain before potentially spreading to involve the entire brain, leading to a generalized seizure, also referred to as a secondarily generalized seizure. Generalized seizures involve abnormal electrical activity throughout the brain and may result in loss of consciousness or widespread physical symptoms.
Globally, epilepsy impacts around 50 million individuals. Despite the availability of antiepileptic drugs (AEDs), approximately 30-40% of patients continue to experience seizures, highlighting significant gaps in treatment. While epilepsy can onset at any age, it is most commonly diagnosed in individuals aged 18 and younger as well as the elderly. Given the diverse causes and clinical presentations of pediatric epilepsy, prognoses vary widely, necessitating tailored treatment approaches for each patient.