Eisai has resubmitted its first-in-class epilepsy treatment Fycompa (perampanel) to the German Federal Joint Committee (G-BA) for reassessment of its additional therapeutic benefits. This follows the G-BA decision in February that Eisai could resubmit their anti-epileptic drug (AED) for early reassessment. The new decision is expected to be published within 6 months. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1]
"We are very pleased that the G-BA has approved our request for an early benefit reassessment of Fycompa," commented Gary Hendler, President & CEO, Eisai EMEA. "The clinical benefit of Fycompa has been recognised in approximately 3,000-4,000 people with epilepsy in Germany since its launch in September 2012 and our first concern throughout this process has been for them. We firmly believe that innovative treatment options are desperately needed for people with this serious condition and believe that the G-BA will reconsider its original position and not effectively deny very ill patients the clinical benefit that Fycompa offers people with partial epilepsy again."
Eisai temporarily suspended perampanel from distribution in Germany (Aussetzen des Vertriebes) in June 2013 following the previous negative G-BA ruling and established a programme for continued supplyof perampanel (Fycompa) free of charge to German pharmacies through individual import (managed by Clinigen Group plc) to ensure that people with epilepsy continue to receivetreatment with perampanel (Fycompa), whilst the G-BA consider the resubmission.
"There still remains a very high need for effective new treatments to reduce seizures in patients with refractory partial epilepsy in Germany. The early resubmission of Fycompa for benefit reassessment is a positive step forward as it means that doctors and patients may soon be able to access a treatment option with proven clinical benefits through the usual way of distribution," commented Professor Bernhard Steinhoff, from Epilepsiezentrum Kork, Kehl-Kork, Germany.
In Germany, approximately one in every 200 people has epilepsy, which equates to an estimated 400,000 people in the country who live with the condition.[2] Epilepsy is one of the most common neurological conditions in the world.[3] The successful treatment of partial onset seizures remains a challenge as over 30% of patients do not achieve seizure freedom despite appropriate therapy with AEDs.[4]
Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only approved AED in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread.[5]
Eisai is a leading research and development based pharmaceutical company. The company's Corporate Philosophy is to give first thought to patients and their families, and to increase the benefits that health care provides to them. Eisai calls this philosophy human health care (hhc). Eisai believes that the hhc philosophy is its primary objective and that only through focussing on the needs of the patient and the wider global healthcare system that sales and earnings will be generated. Guided by our hhc philosophy, Eisai will continue to work to achieve sustainable enhancement of value through its business activities worldwide.
NotestoEditors
About Perampanel
Perampanel is licensed in the European Union (EU) as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures.[1]