Eisai's Antiepileptic Drug Fycompa® (Perampanel) Gains New Indications in China for Monotherapy and Pediatric Use

SHANGHAI, Aug. 3, 2021 /PRNewswire/ -- On July 30, 2021, Eisai's originally developed anti-seizure medication (ASM) FYCOMPA® (generic name: perampanel) was approved in China for a new indication for the treatment of partial-onset seizures (with or without secondary generalization) in adults and children aged 4 years and older.

Fycompa® is a first-in-class antiepileptic drug developed by Eisai Tsukuba Research Laboratories, a highly selective, non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitability associated with seizures.

Fycompa (perampanel) was approved in September 2019 through priority review for the adjunctive treatment of partial-onset seizures (with or without secondary generalized seizures) in adults and pediatric patients aged 12 years and older. In October 2020, the National Medical Products Administration (NMPA) accepted and approved its application for the indications of monotherapy and partial-onset seizures in pediatric patients aged 4 years and older. Additionally, in December 2020, Fycompa was officially included in China's *National Reimbursement Drug List (2020 Edition)*.

Currently, Fycompa has been approved for marketing in over 70 countries and regions, including Japan, the United States, China, Europe, and Asia. In the United States, Japan, and the European Union, Fycompa is approved as monotherapy or adjunctive therapy for patients aged 4 years and older with partial-onset seizures (with or without secondary generalization), and as adjunctive therapy for patients aged 12 years and older with primary generalized tonic-clonic seizures. An oral suspension formulation suitable for patients with swallowing difficulties and pediatric patients has also been launched. To date, Fycompa has been widely used to treat over 300,000 patients worldwide (across all indications combined). Eisai is currently conducting a global Phase III clinical trial (Study 338) to evaluate the drug for the treatment of rare seizures associated with Lennox-Gastaut syndrome (LGS). Additionally, the development of an injectable formulation is ongoing.

In 2019, the WHO elevated epilepsy to the level of a public health priority, urging global action to ensure its appropriate management. In China, there are approximately 9 million patients with epilepsy, including 6 million with active epilepsy, and an estimated 400,000 new cases occur annually, more than half of whom are adolescents. Antiepileptic drug therapy is the most critical and fundamental treatment for epilepsy and is typically the first-line intervention. With the market introduction of third-generation antiepileptic drugs, this clinical need has been further optimized and effectively addressed.

Eisai has designated neuroscience, including epilepsy, as a priority therapeutic area. With the approval of new indications, the company will continue to pursue its mission of providing effective treatments for epilepsy to more patients worldwide. Eisai is committed to meeting the diverse needs of patients with epilepsy and their families, contributing to the improvement of their well-being.