BRIEF—FDA priority review for Fycompa sNDA

The US Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for Priority Review for Japanese pharma major Eisai’s antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years).

The submission also proposes a pediatric indication for adjunctive use for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy (ages 2 to less than 12 years).

The sNDA application includes both the Fycompa tablet and oral suspension formulations.

"The incidence of seizures in the pediatric age group has been steadily increasing in the US where an estimated 470,000 children are living with epilepsy today. Approximately 30 percent of all patients have uncontrolled seizures, and it is crucial that we do whatever we can to help these patients achieve the ultimate goal of seizure freedom," said Trevor Resnick, Pediatric Neurologist at Nicklaus Children's Hospital.

He added: “Approximately 71 percent of all people living with epilepsy miss at least one dose of their medication per month, and 45 percent of those missed doses result in a subsequent breakthrough seizure. Fycompa's long, 105 hour half-life may play an important role for patients who miss doses."

Fycompa is currently approved as therapy (adjunctive and monotherapy uses) for POS Fycompa with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older, and as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older. To date, more than 100,000 patients have been treated with Fycompa worldwide across all indications.