HATFIELD, England, September 18, 2012 /PRNewswire/ --
Fycompa(R)(perampanel), is launched today in Denmark as the first in an entirely new class of treatment for uncontrolled partial epilepsy (the most common form of the condition). The new therapy has demonstrated efficacy in partial onset seizures, in particular with secondary generalisations. It is indicated as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1] Following the UK and Germany, Denmark is one of the first countries in Europe to launch Fycompa.
Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in causing seizures.[2] 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.
There are approximately 46,000 people in Denmark living with epilepsy.[3] The successful treatment of partial-onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20 - 40% of patients with newly diagnosed epilepsy will become refractory to treatment.[4]
"Perampanel provides doctors and patients with a very welcome new option for the treatment of partial-onset epilepsy that could potentially help people in Denmark living with epilepsy achieve better seizure control", said Elinor Ben-Menachem, Professor of Neurology and Epilepsy at the Institute for Clinical Neurosciences, Sahlgrenska Academy, Gteborg, Sweden. "In addition, it has the added benefit of once daily dosing, which will optimise adherence in patients already receiving therapy."
Perampanels approval by the European Commission (EC) was based on three global pivotal Phase III studies with 1,480 subjects. These randomised, double-blind, placebo-controlled and dose-escalated studies showed consistent results in the efficacyand 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 Danish price for Fycompa was received from the Danish Health and Medicines Authority on 5 September 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 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.
Notes to Editors
About perampanel
Original post:
New First-in-Class Treatment Fycompa® Launches in Denmark for Most Common Form of Epilpesy