Eisai Submits New Indication Application in China for Perampanel Tablets to Treat Primary Generalized Tonic-Clonic Seizures

On March 24, the CDE website showed that Eisai's self-developed product Perampanel was submitted for a new indication in China, for the treatment of generalized tonic-clonic seizures in epilepsy.

Perampanel is a highly selective, non-competitive AMPA receptor antagonist that exerts its antiepileptic effects by inhibiting glutamate-induced neuronal hyperexcitability through non-competitive binding to AMPA receptors on the postsynaptic membrane. In July 2012, perampanel was first approved for marketing in the European Union as an adjunctive treatment for focal-onset seizures with or without secondary generalization in epilepsy patients aged 12 years and older.

In June 2015, perampanel was approved by the FDA to expand its indication to tonic-clonic seizures (PGTC) in epilepsy patients aged 12 years and older, based on positive data from the Phase III E2007-G000-332 study.

The results showed that the reduction in seizure frequency of PGTC epilepsy was significantly greater in the perampanel group than in the control group (-76.5% vs -38.4%; P<0.0001). Moreover, a higher proportion of patients in the perampanel group achieved a ≥50% reduction in both PGTC and total seizure frequency within 28 days (64.2% vs 39.5%).

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