FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

20 October 2014

Japanese drug major Eisai (TYO: 4568) has had a supplemental New Drug Application for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary generalized tonic-clonic seizures accepted by the US Food and Drug Administration.

The drug, marketed by Eisai as Fycompa CIII, was approved by the FDA in October 2012 and became available in January 2014. It is currently approved as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 and over.

Lynn Kramer, chief clinical officer, president, neuroscience and general medicine PCU Eisai Product Creation Systems at Eisai, said: "Eisai remains dedicated to advancing epilepsy care for patients, and the acceptance of this sNDA represents an important step toward expanding treatment options for patients whose PGTC seizures are not controlled by their current medication.”

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