Eisai's Perampanel Gains Two New Indications in China for Pediatric and Monotherapy Use in Partial-Onset Seizures

Text | Sunshine

On July 30, the official website of the NMPA indicated that two new indications for Eisai's perampanel were approved: for the treatment of focal onset seizures in patients with epilepsy aged ≥4 years, and as a monotherapy for the treatment of focal onset seizures.

Epilepsy is a chronic neurological disorder characterized by recurrent seizures. Seizure presentations vary among patients, typically occurring suddenly and without apparent cause. Clinical manifestations may include convulsions, muscle spasms, loss of consciousness, fixed gaze, and staring. The condition is characterized by its paroxysmal, transient, recurrent, and stereotypical features. Epilepsy can occur at any age but is most prevalent in individuals aged 18 years and under, as well as in the elderly population.

According to statistics, there are approximately 60 million patients with epilepsy worldwide, with about 9 million in China. Among them, roughly 60% are affected by focal epilepsy, and approximately 30% of patients fail to achieve adequate seizure control with existing anti-epileptic drugs. Epilepsy remains a disease with a significant unmet medical need.

Perampanel is a highly selective, non-competitive AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist that reduces neuronal hyperexcitability associated with seizures by targeting and inhibiting glutamate activity at postsynaptic AMPA receptors.

Chemical Structure of Perampanel

According to the PharmaCube NextPharma database, the currently approved indications for perampanel are: 1) focal seizures; 2) generalized tonic-clonic seizures. Currently, perampanel has been approved and marketed in over 70 countries and regions worldwide.

According to Eisai's annual report, since perampanel was launched in 2012, its sales have grown steadily year on year. Sales revenue in 2020 reached 26.7 billion yen.

In September 2019, perampanel was approved for marketing in China as an adjunctive therapy for patients aged 12 years and older with partial-onset seizures (with or without secondary generalization). This latest approval expands the indicated patient population to include individuals aged 4 years and older, and extends the indication to monotherapy for partial-onset seizures, providing a new treatment option for epilepsy patients in China.