HATFIELD, England, July 27, 2012 /PRNewswire/ --
First region in the world to approve this new class of treatment for partial
epilepsy
The European Commission (EC) has issued Marketing Authorisation Approval for the use of Fycompa(R) (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1] With the ECs approval, the European Union is the first region in the world to approve Eisais perampanel.
Discovered and developed by Eisai in Europe and Japan, perampanel is currently the only approved anti-epileptic drug (AED) to selectively target AMPA receptors, which play a central role in seizure generation and spread.[2] Epileptic seizures are primarily mediated by the neurotransmitter glutamate.[3] As an AMPA receptor antagonist, perampanel selectively targets the transmission of seizures by blocking the effects of glutamate. This mechanism of action, which is different to that of current AEDs, means that perampanel is the first approved AED in this new class of treatment.[4, 5] Perampanel is the first treatment to exhibit clinical efficacy in Phase III clinical trials against partial-onset seizures by selectively (non-competitively) blocking postsynaptic AMPA receptor-mediated excitatory neurotransmission.[6, 7] 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 UK will also be the first country to launch perampanel in September 2012.
"Improving seizure control is one the most pressing concerns in the care of people with epilepsy. The European approval of perampanel is exciting as it represents a completely new option for doctors to use in the fight against uncontrolled partial epileptic seizures. The epilepsy community is eagerly anticipating the availability of a new AED with unique mode of action, " commented Professor Bernhard Steinhoff, Professor of Neurology, Medical Director and Executive, Epilepsy Centre, Kehl-Kork, Germany.
There are an estimated six million people living with epilepsy in Europe[8] and the successful treatment of partial-onset seizures (the most common type of epilepsy), remains a challenge for some people with epilepsy. The incidence of uncontrolled partial epilepsy remains high despite many new AEDs, and between 20 - 40% of people with newly diagnosed epilepsy will become refractory to treatment.[9]
The EC based its approval decision on clinical data from three pivotal Phase III, global, randomised, double-blind, placebo-controlled, dose-escalation studies which examined 1,480 people with partial epilepsy. Each of the studies showed consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in people with partial-onset seizures (with or without secondary generalisations).[7, 10, 11] In addition, perampanel delivers the benefit of once-daily dosing, thereby it may help to reduce the potential pill-burden a person with epilepsy may experience.[12] The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls, and ataxia.[7, 10, 11]
Perampanel received positive opinion from the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) in May 2012. The US Food and Drug Administration (FDA) also accepted the resubmission for perampanel New Drug Application in March 2012.
The development of perampanel underscores Eisais human health care 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 people with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
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European Commission Approves Eisai´s Fycompa® (perampanel)