The EC approved expanded use of Eisai’s once-daily epilepsy drug Zonegran® (zonisaminde) to include monotherapy against partial seizures (with or without secondary generalization) in adults with newly diagnosed epilepsy. The drug had previously been approved as adjunctive therapy.
Approval in Europe for the monotherapy indication was based on a trial in 583 newly diagnostic adult partial epilepsy patients that demonstrated the safety and noninferiority of once-daily zonisaminde compared with twice-daily controlled-release carbamazepine monotherapy in terms of seizure-free response rates at six months. “Zonegran is already a successful, once-daily add-on therapy for patients with epilepsy,” comments Bettina Bauer, head of EMEA epilepsy business unit at Eisai Eruope. “Zonegran is one of only six anti-epilepsy drugs available as monotherapy.”
Also today Eisai confirmed that the EMEA has accepted for review its application for approval of Zonegran as an adjunctive therapy for pediatric patients aged six years and over with partial seizures. The firm is developing Zonegran in Europe under license from Dainippon Sumitomo Pharma. Sales of the drug in Europe were JPY 4.5 billion (about $60 million) in fiscal year 2011, up from JPY 4.3 billion in 2010.