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news.Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), will be launched in the Netherlands on 13 May 2014.
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The new 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 critical role in the spread of seizures. This mechanism of action is different to other, currently available AEDs.
In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.
Stichting Epilepsie Instellingen Nederlands research and development director Dr Ley Sander noted that nearly a third of people with partial epilepsy continue to experience seizures despite the treatment options currently available.
"New treatment options such as perampanel are welcomed by both doctors and people with epilepsy in the Netherlands. In addition, it has the added benefit of once daily dosing, which may optimise adherence in patients already receiving therapy," Dr Sander added.
Perampanel’s reimbursement approval in the Netherlands is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307).
The three global pivotal studies show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.
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 favorable tolerability profile over the longer term.
Eisai medical director Dr Gerard Vermeulen noted that the company is delighted to announce the launch of perampanel in the Netherlands.
"As an emerging leader in the field of epilepsy, Eisai is committed to developing innovative therapies to meet the unmet needs of people with epilepsy who need alternative treatment options to help them achieve seizure control," Dr Vermeulen added.
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.