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SMC first to give Fycompa thumbs-up

Published on 12/12/12 at 11:40am
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The Scottish Medicines Consortium (SMC) has approved Eisai’s first-in-class epilepsy drug Fycompa for use in the NHS in Scotland - the drug’s first health technology assessment anywhere in the world.

Fycompa (perampanel) has a different mechanism to current anti-epileptic drugs and blocks postsynaptic glutamate AMPA receptors. Seizures are primarily mediated by the neurotransmitter glutamate.

The SMC has said the the once-daily pill can be used as a second-line adjunctive treatment in patients with refractory partial-onset epilepsy. The successful management of partial-onset - the most common form of epilepsy - is a key goal in this therapy area.

Fycompa’s cost effectiveness in Scotland was secured by Eisai’s patient access scheme for the treatment. 

Around six million people in Europe suffer from epilepsy and Eisai has high hopes for Fycompa in the UK, opening a new solid dose production line in September at its base in Hatfield, Hertfordshire.

This makes it the first of the company’s drugs to be manufactured outside of Japan.

SMC based its decision on three placebo-controlled double-blind studies and took into account overall costs compared with existing antiepileptic drugs. The cost analysis took in inpatient visits, A&E services, outpatient and GP visits as well as the price of the drug itself.

Eisai already 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.

GlaxoSmithKline and Valeant’s Potiga (ezogabine) was approved in the US last year and Fycompa got the nod from the FDA in October.

But Eisai’s brand is poised to take advantage of tectonic shifts in the epilepsy market, with big drugs including GSK’s blockbuster Lamictal and Johnson & Johnson’s Topomax, due to go off patent.

Eisai launched Fycompa in the UK in September prior to a roll-out in EU member states including Germany, with the majority of the rest of Europe expected to follow by September 2013.

Adam Hill

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