December 19, 2012
Announcement Regarding Applications for Approval of Pediatric Indication and Additional Formulation of Topina®, an Antiepileptic Agent
Tokyo, Japan, December 19, 2012---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed applications in Japan for marketing authorization approval of Topina® (topiramate), which consist of an additional indication as an adjunctive therapy with other antiepileptic drugs for the treatment of partial onset seizures in pediatric epileptic patients aged two years or older and a new formulation of fine granules.
Since the launch in September 2007, Topina® Tablets have been used due to the excellent clinical efficacy and safety in many epileptic patients for the treatment of partial onset seizures inadequately controlled with other antiepileptic drugs.
Clinical trials of the fine granules and tablet formulations in the treatment of adjunctive therapy for pediatric epileptic patients were conducted by Kyowa Hakko Kirin, and demonstrated their efficacy and tolerability. Based on the results, Kyowa Hakko Kirin has filed an application for an additional pediatric indication. In addition, a new dosage form application of the fine granules which is more appropriate for administration in children was submitted at the same time.
Kyowa Hakko Kirin is endeavoring to contribute to the treatment of central nervous system diseases through the further development of antiepileptic agents and the provision of related information.