Eisai has made the UK the first country in Europe to launch its novel epilepsy treatment Fycompa.
Recommended by the European Medicines Agency (EMA) in May, 2012, the drug is the first in a new class of treatment for uncontrolled partial epilepsy and is indicated as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.
Japan-based Eisai's decision to choose the UK as a launch market for Fycompa (perampanel) comes at a time of increasing criticism regarding the country's speed of access to new medicines.
But president and CEO of Eisai EMEA Gary Hendler said the UK market was chosen as it was the “last free pricing market in Europe” sending an interesting message to the Department of Health and ABPI ahead of drug pricing negotiations.
In addition, Hendler also said further reasons for the decision to launch the drug in the UK first were Eisai's choice to make the country its regional hub in Europe; the discovery of the drug in the UK through a partnership with UCL; and the use of the company's Hatfield plant to manufacture Fycompa.
Eisai plan to market the drug on a local basis, targeting PCTs and hospitals, following a decision from the National Institute of Health and Clinical Excellence (NICE) to not consider the drug for review.
Discussing whether this would affect uptake in the country, Hendler reference Eisai's own Zebinix and UCB's Vimpat, neither of which were reviewed by NICE, and GlaxoSmithKline's epilepsy treatment Tobalt, which was approved by NICE last year.
Comparing uptake, however, both Zebinix and Vimpat had slow starts before achieving fast acceleration, whereas uptake for Trobalt was “very, very slow” according to Hendler.
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Fycompa has demonstrated in clinical trials it can reduce the frequency of seizures in people with epilepsy and the drug is available in a once-daily dosage to be taken at bedtime.
It becomes the first licensed anti-epileptic drug to target AMPA receptors, which play a role in the spread of seizures, and the drugs method of action and adolescent indication complement Eisai's existing portfolio of epilepsy products.
“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,” said Dr Fergus Rugg-Gunn, consultant neurologist at the UCLH NHS Foundation Trust.
“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.”
David Ford, chief executive of Young Epilepsy, emphasised the drug's potential in a younger population.
He said: “In order for young people living with epilepsy to reach their full potential in education, employment and social interaction, their seizures need to be under control as far as possible and their condition needs to be better understood by those around them.”
Eisai plans to launch the drug in Austria, Germany and Denmark next week, before further launches across Europe.