Epilepsy Drug Approved By FDA for Use in Children

The FDA has expanded the indication of the antiepileptic drug perampanel (FYCOMPA, Eisai) CIII for monotherapy and adjunctive use in pediatric patients aged 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures.

The FDA has expanded the indication of the antiepileptic drug perampanel (FYCOMPA, Eisai) CIII for monotherapy and adjunctive use in pediatric patients aged 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures.

The approval includes both FYCOMPA tablet and oral suspension formulations.

“We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai, in a prepared statement.

An estimated 470,000 children in the United States are living with epilepsy, according to Eisai. Up to 40% will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures.

“Taking an AED as prescribed every day is a critical part of reaching the goal of seizure freedom for pediatric patients,” said Jesus Eric Piña-Garza, MD, pediatric neurologist, Tri-Star Medical Group Children's Specialists, in a prepared statement. “With FYCOMPA, children and their parents now have a once-daily dosing option with a long half-life that can fit into their increasingly busy lives.”

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