Zebinix eslicarbazepine acetate regulatory update

Eisai Co. Ltd. (Tokyo:4523, Tokyo, Japan) said the Italian Medicines Agency (AIFA) approved the reimbursement of Zebinix eslicarbazepine as an adjunct treatment for partial-onset seizures in adult epileptics with or without secondary generalization. Earlier this year, Dainippon's Sunovion Pharmaceuticals Inc. subsidiary launched the product as Aptiom in the U.S. (see BioCentury April 14).

Dainippon gained U.S. and Canadian rights to the voltage-gated sodium and T-type calcium channel blocker through its 2009 acquisition of Sepracor Inc., which had exclusive rights from Bial-Portela. Aptiom is also under review in Canada. Sunovion plans to submit an sNDA to FDA for Aptiom as monotherapy next half. ...