FDA Prioritizes Review of Fycompa for Pediatric Seizures

Today, Eisai Inc. announced that the US Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) and granted Priority Review to the company’s antiepileptic drug perampanel (Fycompa) for monotherapy and adjunctive use for the treatment of partial-onset seizures with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years).

The sNDA also suggests 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 submitted application covers both the perampanel tablet and oral suspension formulations.

"The FDA's Priority Review designation for this sNDA underscores the urgent need for more treatment options like Fycompa in the pediatric population," Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai, said in a statement.

Perampanel was previously approved by the FDA as a monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years or older in 2017.

The current sNDA incorporates data from Study 311, an ongoing open-label, multicenter, phase 3 study with an extension phase that evaluated safety, tolerability, and efficacy of perampanel oral suspension as an adjunctive therapy in children, ages 4 through 11, with inadequately controlled POS or PGTC seizures. The study included 180 patients, 149 with POS and 31 with PGTC seizures, taking a mean daily dose of 6 mg.

"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% 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, MD, Pediatric Neurologist at Nicklaus Children's Hospital. "Approximately 71% of all people living with epilepsy miss at least one dose of their medication per month, and 45% 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."

Parampanel is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. It is classified as a federally controlled substance (CIII) by the US Drug Enforcement Administration.

"We are committed to working with the FDA to bring forward more treatments for young patients to help physicians achieve seizure freedom, a critical goal in epilepsy care," said Kramer.