Swissmedic, the Swiss Agency for Therapeutic Products, has accepted perampanel for review in the treatment of partial-onset seizures in patients with epilepsy.
Perampanel is a first-in-class, highly selective, non-competitive AMPA-type glutamate receptor antagonist.
“The acceptance by Swissmedic to review perampanel for use in Switzerland is a positive step forward in the approval process,” said Dr Bettina Bauer, Head of the EU Epilepsy Business Unit at Eisai Europe.
“Uncontrolled seizures can severely impact patient quality of life and a new anti-epileptic drug that offers improved seizure control is an important development in the management of epilepsy.
“Perampanel is an exciting new product that has the potential to address the strong unmet need in epilepsy patients.”
The efficacy, safety and tolerability of perampanel has been demonstrated by three Phase III global, randomised, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients.
The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalised seizures, and evaluation for dose response.
Each of the studies showed consistent results in the efficacy and tolerability of perampanel in patients with partial-onset seizures.
Perampanel also has the benefit of once-daily dosing, helping to reduce the potential pill-burden a person with epilepsy may experience.
In June 2011, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) for perampanel as a treatment for partial-onset seizures in patients with epilepsy.