Pediatric Antiepileptic Drug Gets FDA Nod

SEPTEMBER 28, 2018
Kevin Kunzmann
The US Food and Drug Administration (FDA) has approved antiepileptic drug perampanel (FYCOMPA) CIII for monotherapy and adjunctive use in pediatric patients for the treatment of partial-onset seizures (POS).

The therapy, from Eisai Inc., has been approved for patients aged 4 years or older, who suffer from POS with or without secondarily generalized seizures, as both a tablet and oral suspension formulation. Approximately 470,000 children in the US currently live with epilepsy, and nearly half will not achieve seizure freedom with their existing therapies.

Perampel’s indication in pediatric patients with epilepsy was supported by the efficacy results of a trio of phase 3 clinical trials involving adult patients with POS. Its safety was also evaluated in a pair of studies in pediatric patients with epilepsy, in which a total of 225 patients received perampel—110 for at least 6 months, and 21 for at least 1 year.

The final results of these approval-supporting studies are planned to be presented at an upcoming medical meeting, according to Eisai. Originally approved for adjunctive use in POS in 2012 then later approved as an adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older, perampanel is a selective non-competitive AMPA receptor agonist which exerts antiepileptic effects by a clinically unknown mechanism.

As a once-daily dosing option with an elongated half-life, perampanel becomes a viable treatment option for pediatric patients. It fits into Eisai’s “tireless” work to provide treatment options across all ages for seizure control and overall freedom, Lynn Kramer, MD, chief clinical officer and chief medical officer of Eisai Neurology Business Group, said.

“We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy,” Kramer said. “This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need.”

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