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Eisai launches epilepsy drug in UK

Published on 14/09/12 at 11:31am
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Eisai has launched its first-in-class epilepsy drug Fycompa in the UK, prior to a roll-out in EU member states including Germany.

Once-daily pill Fycompa (perampanel) has been indicated as as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in patients aged 12 years and older.

The drug, an AMPA receptor antagonist, has a different mechanism to current anti-epileptic drugs and blocks postsynaptic glutamate AMPA receptors - seizures are primarily mediated by the neurotransmitter glutamate.

European approval for Fycompa was based on three global Phase III studies, taking in 1,480 epilepsy sufferers, which showed consistent efficacy and tolerability.

Primary and secondary endpoints were percentage change in seizure frequency, 50% responder rate, percentage reduction of complex partial plus secondarily generalised seizures and evaluation for dose response.

Gary Hendler, chief executive of Eisai EMEA and Russia, acknowledges that doctors will not prescribe Fycompa because of its mode of mechanism alone, but he argues that having a new treatment option is important.

“The patient population in the trials had two or three anti-epileptics on board before they got to Fycompa,” he told InPharm. “Where the data stands out is in the sicker patients. Fycompa has been outstanding. The other benefit is that it has a half-life of 70 hours so it’s genuinely a once-a-day drug.”

The successful management of partial-onset seizures, the most common form of epilepsy, is a key goal in this therapy area.

Fycompa was launched in Austria at the same time as the UK, with Germany and Denmark expected to follow shortly and the majority of the rest of Europe by September 2013.

The FDA is set to give Fycompa the green light on 22 October. It had asked for more information earlier this year but Hendler insisted this was down more to questions over presentation of data than substantial doubts about the drug itself.

Eisai has several treatments in this field: Zonegran and Zebinix for adult patients with partial-onset seizures, and Inovelon for seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy.

“I don’t think we’ll cannabalise our own business at all,” continued Hendler, dismissing the idea that Fycompa might be a threat to these products. “We have a branded portfolio and we’re going to be selling that portfolio.”

The epilepsy market is at an interesting stage for pharma companies: last year GlaxoSmithKline and Valeant’s Potiga (ezogabine) was approved by the FDA - but some big drugs, including GSK’s blockbuster Lamictal and Johnson & Johnson’s Topomax, are due to go off patent.

An estimated six million people in Europe suffer from epilepsy with more than 30,000 people dying from the disease each year.

Adam Hill

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