Eisai Gains Approval in Japan for Fycompa

Eisai Gains Approval in Japan for Fycompa

By, Admin 24 February 2024

Ligand Partner Eisai Receives Approval in Japan for Injection Formulation of Antiepileptic Drug Fycompa®

Ligand Pharmaceuticals Inc  has announced that Eisai Co., Ltd., its partner, has received approval for the injection formulation of their antiepileptic drug (AED) Fycompa® (perampanel) from the Japanese Ministry of Health, Labour and Welfare. This approval, granted in January 2024, allows Fycompa to be used as an alternative therapy in cases where oral administration is temporarily not feasible. Fycompa, incorporating Ligand's Captisol® technology, is a groundbreaking AED discovered at Eisai’s Tsukuba Research Laboratories. It functions as a highly selective, noncompetitive AMPA receptor antagonist, targeting glutamate activity to reduce neuronal hyper-excitation associated with seizures.

Praises from partner 

  • Ligand, emphasized the importance of uninterrupted epilepsy treatment and praised Eisai for enabling this through the new formulation of Fycompa. 
  • Under the partnership agreement established in 2017, Ligand is set to receive royalties from the sales of intravenous Fycompa.

About Perampanel

  • Perampanel, the active ingredient in Fycompa, is a first-in-class AED developed by Eisai. It acts by selectively inhibiting AMPA receptors, thereby mitigating neuronal hyperexcitation linked to seizures. 
  • Perampanel is approved in numerous countries for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 12 and older, with varying approval ages across regions.

About Technology : Captisol

  • Captisol®, the technology utilized in Fycompa's formulation, is a patented cyclodextrin designed to enhance drug solubility and stability. 
  • Developed by scientists at the University of Kansas, Captisol has facilitated the development of several FDA-approved products and is utilized in over 40 partnered programs.

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