Eisai Co., Ltd. has recently received marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for its injection formulation of the antiepileptic drug (AED) Fycompa® (perampanel) in Japan. This approval allows for the use of Fycompa as an alternative therapy when oral administration is temporarily not possible, such as during surgery.

Fycompa, a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories, is a highly selective, noncompetitive AMPA receptor antagonist designed to reduce neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. While Fycompa is available in Japan in oral tablet and fine granule formulations, there are concerns about the risks of seizures associated with interruptions in oral administration, especially during periods when the drug cannot be taken orally.

To address this concern, Eisai developed an injection formulation of Fycompa to cater to patients who are temporarily unable to use oral administration. The supplementary new drug application for this new route of administration was filed in August 2022, leading to the recent approval.

Eisai, with a focus on neurology and epilepsy, considers providing "seizure freedom" to a greater number of patients its mission. The company remains committed to addressing the diverse needs of patients with epilepsy and their families.

Perampanel, marketed as Fycompa, is a first-in-class AED discovered and developed by Eisai. It acts as a selective, noncompetitive AMPA receptor antagonist, targeting glutamate activity to reduce neuronal hyperexcitation associated with seizures. Currently approved in over 75 countries, Fycompa is used as an adjunctive treatment for partial-onset seizures in patients with epilepsy aged 12 and older. It is also approved for primary generalized tonic-clonic seizures in various countries.

Epilepsy, a condition affecting millions globally, presents significant unmet medical needs, with 30-40% of patients unable to control their seizures with existing AEDs. Fycompa's approval for injection provides an important alternative for patients facing temporary challenges with oral administration, contributing to Eisai's ongoing efforts in the field of epilepsy treatment.

 

Source: eisai.com

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