Eisai withdraws EU application for additional Aricept indication

Eisai has announced that it has “tentatively” withdrawn its application for an additional indication for Aricept in Europe.

The firm had previously submitted an application for the compound to be indicated as a treatment for severe Alzheimer’s disease the mutual recognition procedure on the continent.

A spokesman for the firm, Takeshi Shimizu stated that the regulatory bodies in Europe called for more data showing the improvement of daily life activities in patients with the disease, Reuters reports.

Mr Shimizu added that the regulatory authorities were satisfied with data submitted by the company relating to improvements in cognition resulting from administration with the compound.

“Eisai will discuss the matter with the European regulatory authorities and review possibilities for resubmission,” the company states.

It adds that the firm will continue in its efforts to help patients suffering from severe Alzheimer’s disease.

Aricept has been approved as a treatment for the condition in a number of worldwide markets, including the US, India, the Philippines and New Zealand, while the compound has been submitted for approval in Japan.

Earlier this year, Eisai announced that Inovelon (rufinamide) its adjunctive treatment for Lennox-Gastuat Syndrome – a severe from of childhood epilepsy – had been awarded marketing authorisation from the European Commission.