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news.Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
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PGTC is one of the most severe forms of generalized seizures, accounting for approximately 60% of generalized epilepsy and approximately 20% of all epilepsy cases.
This application was based on a double-blind, randomized, placebo-controlled, multicenter, parallel-group clinical study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures receiving one to a maximum of three anti-epileptic drugs (AED).
Analysis of the study demonstrates that Fycompa significantly reduced PGTC seizure frequency (primary analysis for the U.S.) and improved responder rates (the percentage of patients who experienced a 50% or greater reduction in PGTC seizure frequency, primary analysis for the EU), the study’s two primary outcome measures, when compared to placebo. In this study, the most common adverse events (=10% in the Fycompa arm and greater than placebo) were dizziness, fatigue, headache, irritability and somnolence. The adverse event profile observed in the study was similar to that observed in other Fycompa studies.
Fycompa is a first-in-class AED discovered and developed by Eisai.
With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
Fycompa is approved in more than 35 countries primarily in Europe and North America, and has been launched in the U.S., Europe and Canada as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older. Furthermore, a clinical study on patients with partial-onset seizures (Study 335) is currently underway in Asia including Japan, and Eisai plans to submit a regulatory application covering both study 332 and study 335 in Japan in fiscal 2015.
Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to Fycompa 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.