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

Ligand Pharmaceuticals Incorporated announced that its partner Eisai Co., Ltd. obtained marketing authorization approval in January 2024 from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible. Fycompa is formulated with Captisol, a Ligand technology.

Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation.

“It is essential that patients with epilepsy continue with their course of treatment, even when they are not able to take their medication orally,” said Todd Davis, CEO of Ligand. “We are excited that our longtime partner Eisai is the company that is making this possible, and that Captisol is once again proving to be an invaluable building block in drug development by enabling a new formulation that will make a major difference in people’s lives.”

Ligand first entered into an agreement with Eisai on this product in 2017. Under the terms of the agreement, Ligand is entitled to a royalty on sales of intravenous Fycompa.