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FDA Approves Eisai's Novel Antiepileptic Fycompa

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Eisai Co. Ltd. (ESALY.PK) has added yet another name to its U.S. epilepsy portfolio, following the FDA approval of novel antiepileptic agent Fycompa to treat seizures on Tuesday.

Fycompa, which has a once-daily dosing regimen, has been approved as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 years and older.

The anti-epileptic drug works by selectively targeting AMPA receptors, which play a central role in seizure generation and spread.

The FDA approval was based on results from three clinical trials that showed improvement in seizure control in patients taking Fycompa compared with those taking placebo.

Given the fact that serious or life-threatening psychiatric (mental) problems were more frequently seen in patients treated with Fycompa in clinical trials, the drug's label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes.

Fycompa won approval in the European Union in July of this year, and is also being evaluated in a phase III study in Asia including Japan.

Zonegran for the adjunctive treatment for adult epilepsy patients with partial-onset seizures and Banzel for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy are Eisai's other antiepileptics marketed in the U.S.

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