Eisai files Fycompa for wider epilepsy use

Eisai is looking to extend the use of its epilepsy treatment Fycompa into use as adjunctive treatment of serious seizures uncontrolled by existing treatment.

Eisai has just submitted the drug to the EMA for use as an adjunctive treatment of primary generalised tonic-clonic seizures (PGTC). Fycompa (perampanel) is currently indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

Generalised tonic-clonic seizures are one of the most dangerous types of seizure - they start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.

Despite already taking up to three medicines to control their epilepsy, the PGTC seizures can be refractory or resistant to treatment in some patients.

Fycompa is part of the 'third generation' of antiepileptic drugs (AEDs), which aim to help patients whose seizures do not respond to current treatment options.

The new drugs are led by UCB's Vimpat (lacosamide). Eisai also has Zebinix/Stedesa (eslicarbazepine acetate) co-marketed with Sunovion and Bial, while GSK/Valeant's Potiga/Trobalt and (ezogabine/retigabine) is another of the new treatments.

However these drugs have not yet overtaken the better established second generation drugs, such as UCB's Keppra and GSK's Lamictal, which are now generically available.

Results from a clinical trial named Study 332 showed that perampanel cuts PGTC seizure frequency and improved responder rates (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's two primary outcome measures, when compared to placebo.

Perampanel targets AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to all other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime. The drug is also the only new-generation partial epilepsy treatment approved to treat adolescents (over 12s) with epilepsy from launch.

The filing of Fycompa for the new indication coincides with Eisai receiving a negative decision from Germany's health technology assessment agency IQWiG for use in its first indication.

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