Eisai has submitted files in the USA and Europe for perampanel, the Japanese drugmaker's new antiepileptic.
The European Medicines Agency has accepted for review the marketing authorisation application for perampanel as a treatment for partial-onset seizures in patients with epilepsy. Eisai has also simultaneously submitted a New Drug Application to the US Food and Drug Administration for the drug to be used as adjunctive treatment.
Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, Eisai notes, saying the submissions are based on three Phase III studies in 1,480 epilepsy patients. The company adds that the drug also has the benefit of once-daily dosing, "helping to reduce the potential pill-burden a person with epilepsy may experience".
Eisai quoted Bernhard Steinhoff of the Kork Epilepsy Centre in Germany as saying that 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”.
Banzel approved in Canada for LGS
Meantime, Eisai has revealed that it has received approval to market the antiepileptic Banzel (rufinamide) in Canada for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children aged four and upwards, as well as adults.
The agent got the green light in Europe in January 2007 and in the USA in November 2008. It is also marketed as Inovelon.