BRIEF—New approval for Fycompa in China

Japanese drugmaker Eisai today announced it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.

Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories.

The agent is a selective, non-competitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.

In China, Fycompa was approved for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy aged 12 years and older in September 2019.

Since its launch in January 2020, it has received approval in July 2021 for the additional indications for monotherapy and adjunctive use in the treatment of partial-onset seizures in patients with epilepsy aged 4 years and older, thereby expanding its contribution to epilepsy patients in China.