New First-In-Class Treatment Fycompa® Launches In Norway For Most Common Form Of Epilepsy

Main Category: Epilepsy
Article Date: 09 Jan 2013 - 0:00 PST


Eisai has launched Fycompa(R) (perampanel) in Norway as a treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1] Perampanel is the first in an entirely new class of treatment for uncontrolled partial epilepsy, the most common form of the condition.

There are more than 45,000 people in Norway with epilepsy.[2] The successful treatment of partial-onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite the availability of many anti-epileptic drugs (AEDs). Currently, between 20 - 40% of patients with newly diagnosed epilepsy will become refractory to treatment.[3]

Perampanel is the first and only licensed AED to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing seizures.[4] 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[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.

"Doctors and patients in Norway will welcome perampanel as a new option for the treatment of partial onset epilepsy. It may help people living with epilepsy to achieve better seizure control," said dr. Karl Otto Nakken from the National Center for Epilepsy, Oslo university hospital. "Perampanel could also help to optimise adherence in patients through once daily dosing, and thereby improve outcomes for these patients and reduce the potential drug burden a person with epilepsy may experience."

The efficacy, safety and tolerability of perampanel have been demonstrated by three Phase III global, randomised, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients. They 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).[5],[6],[7] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[5],[6],[7]

The Norwegian price for perampanel was received from the Norwegian Board of Health Supervision on 15 November 2012. Perampanel received CHMP positive opinion in May 2012, was approved by the EC on 23 July 2012 and first launched in the UK on 13 September 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 development of perampanel 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 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.

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