13 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Eisai has decided to launch its AMPA receptor antagonist Fycompa (perampanel), a first-in-class anti-epileptic agent discovered and developed in-house, in Europe ahead of other regions. The product is for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalized seizures, in patients aged 12 years and older.
Following the launch of the agent in the UK on September 13, Fycompa will also be launched successively in European Union member states such as Germany, Austria and Denmark.
Fycompa is a highly selective, non-competitive AMPA-type glutamate receptor antagonist. Epileptic seizures are primarily mediated by the neurotransmitter glutamate. As an AMPA receptor antagonist, Fycompa reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at
post-synaptic AMPA receptors.
In three global pivotal phase III randomized, double-blind, placebo-controlled, dose-escalation studies which examined 1,480 epilepsy patients with partial-onset seizures, Fycompa consistently demonstrated excellent efficacy across all studies. The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls and ataxia.
Fycompa was first approved by the European Commission in July of this year as the first and only anti-epileptic drug to target AMPA receptors. There are an estimated six million people living with epilepsy in Europe, and it is said that some 33,000 people die from the disease each year. In particular, the successful management of partial-onset seizures, the most common form of epilepsy, remains a significant challenge, with around 30 percent of partial-onset seizure patients in Europe not achieving seizure freedom despite therapy with AEDs.