Eisai announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for extending the use of once-daily Zonegran® (zonisamide) as monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy.
Zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure which is unrelated to any other AEDs. For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions.
In addition to the CHMP recommendation for the use of zonisamide as a monotherapy, Eisai received a positive CHMP opinion for Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondary generalisation, in patients with epilepsy aged 12 years and older. Perampanel is a first-in-class, highly selective, non-competitive AMPA receptor antagonist. Based on today’s recommendation, EU approvals of the therapies are anticipated within three months.
There are an estimated six million people living with epilepsy in Europe and an estimated 50 million people worldwide. The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some patients. The incidence of refractory epilepsy remains high despite many new AEDs and between 20 – 40% of patients with newly diagnosed epilepsy will become refractory to treatment.
“The CHMP positive opinion for the license extension for Zonegran (zonisamide) monotherapy further illustrates Eisai’s commitment to bringing new therapeutic options to patients with epilepsy,” said Dr Bettina Bauer, Head of EMEA Epilepsy Business Unit, Eisai Europe; “Zonisamide is already a successful add-on therapy for patients. The monotherapy indication offers a new treatment option for newly diagnosed patients with epilepsy to help improve their seizure control”.
Commenting on the CHMP positive opinion, Michel Baulac, Head of the clinical department at the Hospital de la Pitie-Salpetriere, Paris, France said; “Less than 50% of our patients have their seizures controlled by their first AED, and only a further 10 – 12 % will achieve seizure-freedom from alternative drugs given as monotherapies. It is therefore important to develop new options to expand the clinician’s treatment armamentarium to help control the patient’s condition.” He added; “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.”
The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 adult newly diagnosed partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study’s primary endpoint was the proportion of seizure-free patients at six months. Zonisamide demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy, similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide was well tolerated and no apparent safety concerns of one year treatment with zonisamide at doses ranging from 300 to 500 mg/day were identified.
The development of zonisamide and perampanel underscores Eisai’s human health care mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.