EMA recommends two Eisai epilepsy drugs

Pf product news Eisai has received recommendations from the European Medicines Agency (EMA) for two of its portfolio of anti-epilepsy drugs (AEDs).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Zonegran (zonisamide) to a monotherapy for partial seizures in adults with newly diagnosed epilepsy.

It has also recommended the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures in patients with epilepsy aged 12 or older.

Epilepsy is a chronic brain disorder that affects an estimated six million people in Europe, and AEDs are a major strategic focus for Eisai in this market.

The recommendation of Zonegran as a monotherapy is important because patients with newly diagnosed epilepsy find combination therapies particularly difficult to tolerate.

Michel Baulac, Head of the Clinical Department at the Hospital de la Pitie-Salpetriere, Paris, France, said: “Monotherapy remains the optimal approach for managing patients with epilepsy. In addition to a good tolerability profile and to the absence of interaction with other drugs, in particular with oral contraceptives, zonisamide offers the added value of a once-daily dosing.”

Fycompa is a new option for the management of partial-onset epilepsy, as it selectively blocks a particular type of seizure-inducing neurotransmission.

“Improving seizure control is one of the most pressing unmet needs in epilepsy patients,” commented Professor Bernhard Steinhoff, Medical Director of the Epilepsy Center at Kehl-Kork, Germany. “Perampanel will be a completely new option for the adjunctive treatment of patients with uncontrolled seizures.”