The European Medicines Agency (EMA) has issued Eisai's once-daily oral epilepsy drug with a monotherapy licence for the most common type of the condition.
It expands Zonegran's European indications and means the drug can now be used to treat partial seizures (with or without secondary generalisation) in adultswith newly diagnosed epilepsy on its own.
Dr Bettina Bauer, head of EMEA Epilepsy Business Unit at Eisai Europe, said: "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.”
“We will be working closely with health authorities and clinicians across Europe to ensure patients have access to this treatment from first diagnosis,” she added.
It is a significant step up for Zonegran, which was first approved in Europe in 2010 as an adjunctive treatment forpartial seizures, because monotherapy is the preferred option for managing epilepsy as it reduces the potential for adverse drug interactions.
The new approval means it will compete directly with Novartis' Tegretol (carbamazepine), compared to which Zonegran's once-daily dosing may be an advantage. Tegretol should be given in a number of divided doses during the day, although initially once or twice-daily dosing is recommended.
Zonegran's approval was based on a phase III trial comparing once-daily Zonegran with twice-daily controlled release Tegretol that involved 583 adults with newly-diagnosed partial-onset epilepsy.
The study's primary endpoint was the proportion of seizure-free patients at six months and it showed Zonegran was effective and well tolerated and met the study's criteria of non-inferiority.
Zonegran is a second-generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure that is unrelated to any other AEDs.
There are an estimated six million people living with epilepsy in Europe and an estimated 50 million people worldwide.
The global epilepsy market is estimated to be worth $4bn and Eisai, whose otherepilepsy drugs include the CHMP-recommended perampenal, Zebinix and Inovelon, has ambitions to become a top-three player in the therapy area.