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Eisai sues DEA over Fycompa scheduling

Pharma company won FDA approval in 2012 but still lacks DEA verdict

Eisai Fycompa perampanel epilepsy

Eisai has resorted to legal action in the US as it struggles to bring its recently-approved epilepsy treatment Fycompa to market.

The pharma company is suing the US Drug Enforcement Administration (DEA) for dragging its heels on classifying Fycompa (perampanel) according to its potential for abuse. Although Eisai secured FDA approval for Fycompa back in October 2012, it is still waiting for the DEA's scheduling verdict.

"The FDA sent its scheduling recommendation for Fycompa to the DEA in January 2013, but seven months later the DEA has not yet begun the scheduling process," said Eisai's US subsidiary in a statement.

The company had planned to launch Fycompa in the US in the second quarter of the year and has already started detailing efforts, sending product information to around 6,000 epilepsy specialists to raise awareness of the potential of the treatment among its target population of some 350,000 patients.

Delay in DEA scheduling was also a factor in the late US introduction of Eisai and Arena 's weight-loss drug Belviq (lorcaserin), which eventually started shipping in the US in June after being approved a year earlier by the FDA.

The company has asked the US Court of Appeals for the District of Columbia to order the DEA to "promptly schedule the company's epilepsy drug so that it can [be made] available to patients", adding the delay is "unreasonable and egregious".

Fycompa was the first epilepsy drug of its kind to be approved for marketing in the US, getting the go-ahead for the treatment of partial-onset seizures in patients aged 12 or over.

Eisai points out that partial-onset seizures occur in about 60 per cent of people with epilepsy and around a third of these patients - equivalent to several hundred thousand people in the US - have seizures that are not controlled.

The first-in-class drug acts as a non-competitive AMPA-type glutamate receptor antagonist and is considered to be one of the brightest stars in Eisai's product pipeline with potential peak sale in excess of $1bn a year. Sales of the drug in Eisai's first fiscal quarter (April to June 2013) came in at 700m yen (around $7m).

The pharma company is being supported in its legal action by the US Epilepsy Foundation. The chief executive of the patient organisation, Phil Gattone, said the delay was frustrating for patients, adding it is "even more disheartening to know that the system is not required to have a clear timeline for consumers".

Eisai has also run into trouble with Fycompa elsewhere. In June the company pulled the product off the market in Germany after saying it was unable to accept the ruling of the country's pricing authority.

20th August 2013

From: Regulatory



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