Eisai Co., Ltd, a research-based human health care company, announced that it will launch its in-house-discovered antiepileptic drug (AED) Fycompa tablets 2 mg and 4 mg (perampanel hydrate) 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 in Japan on May 26, 2016.
Eisai received marketing and manufacturing approval for this formulation on March 28, 2016, and the product has been added to Japan's National Health Insurance drug price list as of today.
Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, Fycompa is a first-in-class AED, available in tablet form as a once-daily oral dose. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. In both a phase III clinical study (Study 335)(1) of adjunctive Fycompa in refractory partial-onset seizures, as well as a phase III clinical study (Study 332)(2) of adjunctive Fycompa in primary generalized tonic-clonic (PGTC) seizures, Fycompa demonstrated a statistically significant reduction in seizure frequency. Furthermore, in Study 332, 30.9% of patients treated with Fycompa were free of PGTC seizures during the 13 week maintenance period (12.3% for placebo). The most common adverse events (>/= 10% in the perampanel arms and greater than placebo) observed in Studies 332 and 335 were dizziness, fatigue, headache, somnolence and irritability.
Epilepsy affects approximately 1 million people in Japan. Epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. PGTC seizures are one of the most common and most severe forms of generalized seizures, accounting for approximately 60% of generalized seizures and approximately 20% of all epilepsy cases. The frequency of generalized tonic-clonic seizures is the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP). As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs, this is a disease with significant unmet medical needs.
Fycompa is currently approved in more than 45 countries and territories, including Europe and the United States, as an adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in adult and adolescent patients with epilepsy 12 years of age and older. Fycompa has been also been approved in more than 35 countries, including Europe and the United States, for the adjunctive therapy of PGTC seizures in patients with epilepsy 12 years of age and older.
Eisai considers neurology a therapeutic area of focus, and by providing Fycompa as a new treatment option in Japan in addition to the AEDs Inovelon and Fostoin as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.