Fycompa launched in Norway, approved in Switzerland
Eisai has launched Fycompa (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. The product has also been approved by Swissmedic for the same indication as in Norway. Perampanel is the first in an entirely new class of treatment for uncontrolled partial epilepsy.
There are more than 45,000 people in Norway and an estimated 70,000 in Switzerland with epilepsy. 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). Perampanel is the first and only licensed AED to selectively target AMPA receptors, a protein in the brain that plays a critical role in causing 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.
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. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.
The Norwegian price for perampanel was received from the Norwegian Board of Health Supervision on 15th November 2012. Perampanel was approved by the EC on 23rd July 2012 and first launched in the UK on 13th September 2012. The FDA accepted the resubmission of an NDA for perampanel in March 2012 and the product was approved on 22nd October 2012.