Eisai has submitted an application to the European Medicines Agency (EMA) seeking approval for the use of its Fycompa (perampanel) medicine to treat paediatric patients suffering with epilepsy.
Fycompa is an oral, antiepileptic drug (AED) discovered and developed by the Japanese pharmaceutical company.
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It has been designed as a highly selective, non competitive AMPA receptor antagonist that targets glutamate activity at the receptors on postsynaptic membranes in order to minimise neuronal hyper excitation.
In Europe, the drug already holds approval as adjunctive therapy to treat partial-onset seizures, with or without secondarily generalized seizures, and primarily generalized tonic-clonic seizures in patients aged 12 years and older.
The application for the expanded indication includes results from Phase II and Phase III clinical trials conducted to assess Fycompa as adjunctive therapy in paediatric patients globally.
In the Phase II trial, the pharmacokinetics, efficacy and long-term safety of adjunctive perampanel were studied in patients aged between two and 12 years.
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By GlobalDataData confirmed long-term safety following 11 weeks of treatment and an extension phase (41 weeks).
The Phase III trial investigated the safety, tolerability and relation between efficacy and blood concentration of the drug when administered as an adjunctive therapy.
This study involved patients aged four to less than 12 years with inadequately controlled partial-onset seizures or tonic-clonic seizures.
Findings demonstrated efficacy similar to that observed in patients aged 12 years and older.
Fycompa has been approved in more than 55 countries, including the US, Japan, Europe and Asia for partial-onset seizures in patients aged 12 years and above.
The drug received the US approval for use in paediatric patients in September last year, and Eisai filed a supplementary new drug application in Japan earlier this month.
The company is also exploring the use of the drug in treating epileptic seizures associated with Lennox-Gastaut syndrome.
