Eisai receives positive CHMP opinion on indication expansion for antiepileptic agent Fycompa as adjunctive treatment of PGTC seizures

Eisai has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa® (perampanel) for the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in adult and adolescent patients from with idiopathic generalised epilepsy.

PGTC seizures are one of the most common and most severe forms of generalised seizures, accounting for approximately 60% of generalised epilepsy and approximately 20% of all epilepsy cases.

Fycompa is a first-in-class AED discovered and developed by Eisai. The agent is a highly selective, non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

Fycompa demonstrated a statistically significant reduction in PGTC seizure frequency

The CHMP based its opinion on a multicentre, double-blind, randomized, placebo-controlled, parallel-group study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with PGTC seizures. As one of the primary endpoints of the study, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo of 39.5%. Additionally, a reduction in PGTC seizure frequency of 76.5% was observed in the Fycompa group, which was statistically significant when compared to a reduction of 38.4% for placebo. Furthermore, 30.9% of patients treated with Fycompa were free of PGTC seizures during the 13 week maintenance period.

Epilepsy affects nearly 2.4 million people in Europe. Fycompa was launched in Europe as an adjunctive treatment for partial-onset seizures (with or without secondary generalised seizures) in patients with epilepsy aged 12 years and older in September 2012. Currently the agent is approved for this indication in over 45 countries, and has been launched in over 25 countries.

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