Safety data for pediatrics was consistent with the safety profile in adult populations, without the need for weight-based dosing.
Lynn Kramer, MD
The FDA has expanded the indication of perampanel (FYCOMPA), Eisai’s antiepileptic drug, for monotherapy and adjunctive use in pediatric patients 4 years of age and older for treatment of partial-onset seizures with or without secondarily generalized seizures; the approval includes both tablet and oral suspension formulations.
The use of FYCOMPA for treatment in patients 4 to 12 years old is backed by efficacy extrapolated from 3 phase III studies of FYCOMPA in adult patients with partial-onset seizures. The final results from the phase III studies supporting the FDA expanded indication will be presented at an upcoming medical conference.
“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,” Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai, 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. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need.”
In the 3 studies, 225 participants received FYCOMPA with 110 participants exposed for at least 6 months and 21 participants for at least 1 year. Although the safety and efficacy data is currently available, Eisai noted that adverse effects were similar to those seen in patients 12 years of age and older.
In May, the FDA granted perampanel priority review as part of the supplemental new drug application for single-agent or adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures. Data backing the FDA’s decision to grant perampanel priority review was backed from 2 ongoing studies: Study 311 and Study 232.
Initially, FYCOMPA was approved in 2012 as an adjunctive therapy for partial-onset seizures, and the indication was later expanded to include patients 12 years of age and older with primary generalized tonic-clonic seizures. Then again, in 2017 FYCOMPA received a monotherapy indication for partial-onset seizures with or without secondarily generalized seizures in those with epilepsy 12 years of age and older.
FYCOMPA, a unique oral medication, has a long half-life and has demonstrated in a pharmacokinetic study that if a missed dose occurs, plasma levels remain quite stable. It’s supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets and a 0.5 mg/mL oral suspension formulation.
Eisai Announces FDA Approval Of FYCOMPA in Pediatric Patients As Young As 4 Years Old For The Treatment Of Partial-Onset Seizures [news release]. Woodcliff Lake, N.J.: Eisai Inc.; 2018. https://www.prnewswire.com/news-releases/eisai-announces-fda-approval-of-fycompa-in-pediatric-patients-as-young-as-4-years-old-for-the-treatment-of-partial-onset-seizures-300721117.html. Accessed Sept. 28. 2018.