Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that on July 26, 2017 (U.S. time), its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) for Eisai’s antiepileptic drug (AED) Fycompa (perampanel) as monotherapy use for the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older.
The FDA’s regulatory pathway for monotherapy use, which was communicated in September 2016, states that “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial-onset seizures to their use as monotherapy for the treatment of partial-onset seizures.” Fycompa is the first AED to be approved as monotherapy for partial-onset seizures in accordance with this regulatory pathway.
Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. It was originally approved in the United States as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures) and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. With the approval of monotherapy for partial-onset seizures, Fycompa can now be prescribed to all patients with partial-onset seizures 12 years of age and older in the United States.