Eisai recently announced the company will launch its novel antiepileptic drug (AED) Fycompa, which is intended as an adjunctive therapy for people suffering from epilepsy and experiencing partial-onset or primary generalized tonic-clonic seizures despite receiving other AEDs. Eisai’s formulation was approved for marketing and manufacturing in March, and the product was recently included in Japan’s National Health Insurance drug price list.
Fycompa (perampanel hydrate) was discovered by the company in-house labs, and is suggested as a once-daily oral tablet. Fycompa is a selective and noncompetitive AMPA receptor antagonist which can reduce neuronal hyperexcitation linked to seizures. The drug influences the postsynaptic glutamate activity at AMPA receptors.
Fycompa was tested in two Phase 3 clinical studies; in a Study 335 of adjunctive therapy in refractory partial-onset seizures, and in a Study 332 of adjunctive therapy in primary generalized tonic-clonic (PGTC) seizures. The studies showed a significant drop in the frequency of seizure occurrence.
In Study 332, 30.9 percent of people who received Fycompa therapy did not experience PGTC seizures over the 13-week study period. The most frequent adverse events included headache, dizziness, somnolence, irritability, and fatigue.
About 1 million Japanese people are affected by epilepsy. The disorder is classified by seizure type: partial-onset seizures account for about 60 percent, and generalized seizures account for about 40 percent of cases. PGTC seizures are the most frequent and serious forms of generalized seizures, occurring in 60 percent of generalized seizures and about 20 percent of all epilepsy cases.
The generalized tonic-clonic seizure is an important risk linked to sudden unexpected death in epilepsy. As about 30 percent of people suffering from epilepsy are not able to manage seizures with current therapeutic approaches, there is a relevant unmet medical need.
Fycompa is approved in 45 countries and territories, including the U.S. and Europe, as an adjunctive therapy of partial-onset seizures in patients suffering from epilepsy who are 12 or older. Fycompa is also approved in 35 countries and territories, including the Europe and the U.S., for the adjunctive treatment of PGTC seizures in people suffering from epilepsy, who are 12 and older.
Eisai focuses on neurology as a therapeutic area, and by providing Fycompa as a new therapy in Japan, the company intends to further address the wider needs of people suffering from epilepsy.