Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China

Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above with epilepsy and primary generalized tonic-clonic seizures.

Fycompa is an oral, selective, non-competitive AMPA receptor antagonist that targets the inhibition of glutamate activity, reducing the hyperexcitability of neurons associated with epileptic seizures. First approved in China in January 2020, the drug was later included in the National Reimbursement Drug List (NRDL) following a price negotiation for the treatment of partial-onset seizures in patients aged 12 and above. In March 2021, Fycompa was named in the second batch of drugs encouraged for generic development in China. An additional indication for treating partial-onset seizures in pediatric patients aged four and above was granted in July 2021.

In April 2023, perampanel was classified under the Category II management in China’s narcotics and psychotropic substances catalog.- Flcube.com

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