Eisai Inc. is seeking priority review from the U.S. Food and Drug Administration for its anti-epileptic drug Fycompa to treat partial-onset seizures in children of age 2 to less than 12 years.
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. A partial-onset seizure affects only a part of the brain.
Fycompa is currently approved as a therapy for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
A generalized tonic-clonic seizure, formerly known as a grand mal seizure, is a type of generalized seizure that affects the entire brain.
The New Jersey-based healthcare company said more than 100,000 patients have been treated with its drug globally across all indications to date.
Eisai said the application, which is based on an FDA draft guidance, includes interim data from an ongoing study with an extension phase that evaluated the safety, tolerability and exposure-efficacy relationship of the drug when administered as an adjunctive therapy in children aged 4 through 11 with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
The study enrolled 180 patients — 148 with partial-onset seizures and 32 with primary generalized tonic-clonic seizures — with an overall mean daily dose of 6 milligrams.
In addition, the application includes data from an open-label pilot study with an extension phase to evaluate the pharmacokinetics, and to generate preliminary data on safety, tolerability, and efficacy of Fycompa when given as an adjunctive therapy in children from 2 to less than 12 years of age with epilepsy.