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Pharmaceutical industry

Eisai's Fycompa Receives FDA Approval for Expanded Indication in Treating Generalized Tonic-Clonic Seizures

Strategic Insights

— 2 min read

Eisai Co., Ltd. has announced that its U.S. subsidiary, Eisai Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion of its antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. This decision was based on a placebo-controlled clinical phase III study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures, which demonstrated a statistically significant reduction in PGTC seizure frequency in the Fycompa group compared to placebo.

Key Takeaways:

  • Fycompa, a first-in-class antiepileptic drug discovered and developed by Eisai, has received FDA approval for an expanded indication as an adjunctive treatment for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
  • The FDA's decision was based on the results of a placebo-controlled clinical phase III study (Study 332), which involved 164 patients aged 12 years and older with PGTC seizures, showing a statistically significant reduction in PGTC seizure frequency in the Fycompa group compared to placebo (-76.5% vs. -38.4%, p<0.001).
  • Fycompa is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
  • The indication expansion of Fycompa allows it to be used as an adjunctive treatment for both primary and secondarily generalized tonic-clonic seizures, providing an additional treatment option for this severe form of epilepsy.
  • Approximately 30% of patients with epilepsy are unable to control their seizures with currently available antiepileptic drugs, making this a significant unmet medical need.
  • Eisai is committed to addressing the diverse needs of patients with epilepsy through its extensive epilepsy product portfolio and ongoing research efforts.

Statistics:

  • 164 patients were involved in the placebo-controlled clinical phase III study (Study 332) of Fycompa in patients aged 12 years and older with PGTC seizures.
  • The study demonstrated a statistically significant reduction in PGTC seizure frequency in the Fycompa group compared to placebo (-76.5% vs. -38.4%, p<0.001).
  • 30% of patients with epilepsy are unable to control their seizures with currently available antiepileptic drugs.
  • Fycompa was approved as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older in the United States in October 2012.

Sources:

  • Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai")
  • U.S. Food and Drug Administration (FDA)
  • Journal article: "Efficacy and safety of perampanel in patients with primary generalized tonic-clonic seizures: a double-blind, randomized, placebo-controlled trial" (Study 332)

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