The European Medicines Agency (EMA) has issued Marketing Authorisation Approval (MAA) to extend the use of once-daily Zonegran(R) (zonisamide) from adjunctive therapy to also include 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.[1] For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions.[2]
Commenting on the MAA, Michel Baulac, Head of the Epilepsy department at the Pitie-Salpetrière Hospital, Paris, France said, "Monotherapy is the optimal treatment approach for managing epilepsy. Therefore, the EU approval of zonisamide monotherapy is of real significance for newly diagnosed epilepsy patients who will, for the first time, be able to access this proven treatment as a first-line option in their care pathway."
There are an estimated six million people living with epilepsy in Europe[3] and an estimated 50 million people worldwide.[4] The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some patients.
"Zonegran is already a successful once-daily, add-on therapy for patients with epilepsy. The new monotherapy indication means this important treatment can now be used in newly diagnosed patients to help improve seizure control," said Dr Bettina Bauer, Head of EMEA Epilepsy Business Unit, Eisai Europe. "Zonegran is one of only six AEDs available as monotherapy, providing doctors with a new option to tailor treatment to individual patient needs."
"The EU approval of Zonegran monotherapy illustrates Eisai's commitment to bringing new therapeutic options to patients with epilepsy," continued Dr Bauer. "We will be working closely with health authorities and clinicians across Europe to ensure patients have access to this treatment from first diagnosis."
The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult 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,[5] similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide demonstrated non-inferiority to carbamazepine, was well tolerated and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.
The development of zonisamide 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.