New anti-epileptic drug approved by EC

News

Hannah Blake

pharmaphorum

The first in a new class of treatment for uncontrolled partial onset of seizures, which is the most common form of epilepsy, has been approved for use in the UK by the European Commission (EC).

Fycompa (perampanel) is the first and only licensed anti-epileptic drug to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of epileptic seizures. It was discovered and developed by Eisai, in the UK and Japan.

The approval was based on three global Phase 3 clinical trials, with 1,480 patients, which showed consistent results in the efficacy and tolerability of Fycomba as an adjunctive therapy in people with partial-onset seizures (with or without secondary generalisations).

"The successful management of partial-onset seizures remains a significant challenge in many epilepsy patients, and the incidence of uncontrolled seizures remains too high, despite existing treatments," "Perampanel provides doctors and patients with an important new option for the treatment of partial-onset epilepsy and may play a key role in improving seizure management in poorly controlled adults and adolescents."

Dr Fergus Rugg-Gunn, consultant neurologist at the UCLH NHS Foundation Trust.

Over 600,000 individuals in the UK have epilepsy and there are around 1000 epilepsy-related deaths each year. This once-daily pill is the only new-generation treatment approved to treat adolescents and adults with epilepsy from launch.

 press-releases-pharmaphorum

Related news:

New First-In-Class Treatment Fycompa® [black triangle drug] Launches Today for Most Common Form of Epilepsy (PR Newswire)

Reference links:

EMA

profile mask

HannahBlake

17 September, 2012