Eisai, a Japanese pharmaceutical company, has disclosed that its Marketing Authorization Application (MAA) for a new first-in-class epilepsy drug, perampanel, had been accepted for review by the European Medicines Agency (EMA). The medication is aimed to treat the most common type of epilepsy (partial-onset seizures) and is a highly selective non-competitive AMPA-type glutamate receptor antagonist.
Epilepsy is a very common neurological condition across the globe with Europe alone believed to have 6 million people who suffer from the condition. Even in today's modern world with drugs being available for most disease forms, it is a challenge to successfully treat episodes of partial onset seizures. Although anti-epileptic drugs are prescribed
to all patients with partial onset seizures, up to 30% never attain complete seizure freedom.
Professor Bernhard Steinhoff, Medical Director and Executive Chief Physician of the epilepsy clinic for adults, Kork Epilepsy Centre, Germany said:
"The acceptance of this application by the EMA is a positive step in the process towards bringing this important therapy to epilepsy patients with uncontrolled partial-onset seizures. "Uncontrolled seizures have a severe impact on patient quality of life and everyday function, so we look forward to the possibility of being able to offer epilepsy patients a new treatment option in the near future."
Three large Phase III, randomized, double-blind, placebo-controlled, dose-escalation studies in which a total of 1,480 epilepsy patients were enrolled globally have clearly demonstrated consistent safety, efficacy and tolerability results for perampanel in effective treatment of partial-onset seizures.
The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
In addition to being a potential new treatment for epilepsy, perampanel has extra benefits. Made possible by once daily dosing of perampanel, one...