Eisai Inc.'s supplemental New Drug Application (sNDA) for Fycompa CIII has been accepted by the U.S. Food and Drug Administration.
Fycompa, a monotherapy treatment, helps fights partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
"This approval is good news for the epilepsy community because it means that more physicians and patients will have access to a single agent option for partial-onset seizures," Dr. Jacqueline French, professor of neurology in the epilepsy division at NYU Langone Medical Center, said.
After first being approved for adjunctive use in POS in 2012, Fycompa went on to receive approval in 55 countries across the globe and treat more than 100,000 patients over a five-year span.
"Approximately one-third of people living with epilepsy have seizures that are not adequately controlled," Dr. Robert Wechsler, medical director of the Idaho Comprehensive Epilepsy Center, said. "Having a new monotherapy option for partial-onset seizures that is once-a-day gives physicians and patients an effective treatment option that has the potential to make a difference in patients' lives."