Eisai applies for new EU and US approval for Fycompa

Eisai is seeking approval for an expanded indication for its established epilepsy drug Fycompa in the US and Europe.

Applications have been submitted to the European Medicines Agency and the US Food and Drug Administration for the drug to be ratified for use as an adjunctive treatment of primary generalised tonic-clonic seizures.

Data from a clinical study has shown the drug is able to significantly reduce seizure rates and deliver improved responses compared to placebo, when used among patients who had failed to achieve seizure control when treated with other therapies.

Fycompa is currently approved in more than 35 countries for as an adjunctive treatment for partial-onset seizures in patients with epilepsy aged 12 years and older.

The company said: "Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families."

This comes after the firm also applied for EU and US regulatory approval of its new drug lenvatinib mesylate as a treatment for thyroid cancer earlier this month.