Eisai launches new class of epilepsy treatment Fycompa in France

May 22 2014

Fycompa^® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has today received reimbursement approval from the Comité Economique des Produits de Santé (CEPS). The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a fundamental role in the spread of seizures. This mechanism of action of perampanel is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime, in a single tablet irrespective of dosage. Perampanel is also the only new-generation partial epilepsy treatment approved to treat adolescents aged 12 and above.

Epilepsy is one of the most common neurological conditions in the world. Around 450,000 people in France live with the condition, with over 100 new cases diagnosed each day. Seizures are the result of an imbalance between inhibition and excitation of neurons in the brain. These imbalances between excitation and inhibition can be caused by various neurochemical mechanisms which are still often poorly understood. Seizures can be triggered by numerous causes: scars from a stroke, cranial traumas, infections, genetic diseases, tumours, malformations. For these reasons there are several types of AEDs with different targets of action, and patients have variable sensitivity to treatment. Thus, about one third of patients are resistant to available treatments and require new therapeutic intervention.

“New treatment options like perampanel becoming available is a very important event for people with partial onset epilepsy in France who live with uncontrolled seizures, and for the physicians who treat them,” said Arnaud Biraben, Neurologist and Epileptologist, Rennes University Hospital, France and President of The French League Against Epilepsy.

Perampanel’s reimbursement approval in France is based on the results from three phase III clinical trials, carried out on patients very resistant to other AEDs, that were randomised, double-blind, placebo-controlled and managed in progressive doses (pivotal trials 304, 305, 306 from the drug registration file) and an open-label extension study (307). The three global pivotal studies yielded consistent results in terms of efficacy and tolerability. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia. Results from the open-label extension study also demonstrate perampanel’s efficacy and favourable tolerability profile over the longer term.

“It is really encouraging to see that the French health authorities recognise the innovative drug status and clinical value of perampanel. The approval for reimbursement in France underscores the importance of this treatment. People who are eligible may now benefit from a novel treatment that may help improve their seizure control,” commented Lysiane Berna-Gallois, Chief Pharmacist, Eisai France.

Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012. 

The launch of perampanel in France underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai seeks to provide innovative medicines for prevention and symptomatic treatment, particularly in the area of epilepsy.