HATFIELD, England, September 13, 2012 /PRNewswire/ --
Europe first region in the world to gain access to this new therapy for
partial seizures
Fycompa(R) (perampanel) is the first in a new class of epilepsy treatments, with demonstrated efficacy in partial onset seizures, in particular with secondary generalisations.[1] In Europe, perampanel is indicated for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1] Following the UK launch, perampanel will also be launched in Germany, Austria and Denmark this month.
Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the initiation and spread of seizures.[2] This mechanism of action is different to any other licensed AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime [1] and significantly, is the only third generation partial-onset epilepsy treatment licensed to treat adolescent epilepsy from launch.
Improved epilepsy care is crucial. Currently, the cost burden of epilepsy in Europe is estimated to stand at EUR20 billion annually, [3] whilst at least one-in-four of the 33,000 deaths attributed to the condition each year in the region are preventable.[4] In particular, the successful management of partial-onset seizures (the most common form of epilepsy) remains a significant challenge in some patients, and incidence of uncontrolled seizures remains high, despite many existing AEDs.
"Perampanel provides doctors and patients with a unique new option for the treatment of drug-resistant partial onset epilepsy that could play an important role in improving seizure control for many people across Europe. It has the added benefit of once-daily dosing, which will optimise adherence in patients already taking more than one antiepileptic drug, " said Professor Martin Brodie, Clinical and Research Director at the Epilepsy Unit in the University of Glasgow, Scotland, "Adolescents and adults with epilepsy need new treatment options. Around one in three will have uncontrolled seizures, even after trying a range of drug options."
The European Commissions (EC) Marketing Authorisation Approval of perampanel was based on three global pivotal Phase III studies of 1,480 people. These randomised, double-blind, placebo-controlled, and dose-escalated studies showed consistent results in the efficacyand tolerability of perampanel, as an adjunctive therapy in patients with partial onset seizures (with or without secondary generalisations).[5], [6], [7] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[5], [6], [7]
Perampanel received CHMP positive opinion in May 2012 and was approved by the EC on 23 July 2012. The FDA accepted the resubmission of New Drug Application for perampanel in March 2012 and has assigned a Prescription Drug User Free Act (PDUFA) target date of 22 October 2012. The worldwide supply of perampanel will be packaged and manufactured at Eisais EMEA (Europe, the Middle East, Africa and Russia) headquarters in Hatfield, UK.
The development of perampanel underscores Eisais human health care (hhc) mission, the companys commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in Europe, the Middle East, Africa and Russia (EMEA) than any other company.
See the article here:
New First-In-Class Treatment Fycompa® Launches Today for People With the Most Common Form of Epilepsy