Perampanel Now Approved by FDA for Patients With Epilepsy as Young as 4 Years
The Food and Drug Administration (FDA) has approved perampanel (Fycompa; Eisai, Woodcliff Lake, NJ) for use in children age 4 to 12 years. Before this decision, perampanel was approved for use only in people age 12 years and up. As for the previous approval, the drug is indicated for use as monotherapy or adjunctive treatment of partial onset seizures with or without secondarily generalizing seizures. Perampanel is available in tablet and oral suspension formulations, and the expanded indication for use in children covers both formulations.
Approximately 1 in 3 patients being treated with AEDs still have breakthrough seizure activity, most frequently because of a missed or skipped dose. Many epilepsy treatments require taking multiple doses of more than 1 medicine throughout the day. This can make it particularly difficult for young patients and their parents to follow treatment as directed. Although the best prevention of breakthrough seizures is not to miss a dose, perampanel has the advantage of once-daily dosing because of its long half-life. Perampanel also appears to remain at stable blood levels even when a dose is missed.
"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. "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."
Approval of perampanel for use in children was based upon 2 studies in 335 children; half were treated with perampanel for 6 months or 12 months and half were given placebo for the same periods. In both studies adverse reactions were similar to that seen in patients age 12 years or more who were treated with perampanel. Efficacy was extrapolated from clinical trials in adult patients.
"Eisai is working tirelessly to provide treatment options for patients of all ages to help better control seizures and achieve the ultimate goal of seizure freedom," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "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."