Eisai Co, Ltd has submitted an application for approval of an additional indication of anti-arrhythmic agent Tambocor 50mg Tablets and Tambocor 100mg Tablets (generic name: flecainide acetate) for the treatment of tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal supraventricular tachycardia, ventricular tachycardia) in paediatric patients in Japan.

Arrhythmia is known to be one of the most common causes of sudden death among children. As there are currently few anti-arrhythmic agents approved for paediatric use in Japan and their indications are limited, it has been one of the issues of unmet medical needs in the country’s paediatric care.

The clinical usefulness of Tambocor in paediatric patients has been widely reported in medical literature. In the United States, the drug can be used in children, and the Council for Paediatric Pharmacotherapy of the Japanese Ministry of Health, Labour and Welfare has discussed the need for making the drug available for the treatment of paediatric patients in Japan. This submission for additional indication has been made in response to the conclusion reached by the committee.

Tambocor Tablets suppress tachyarrhythmia by blocking cardiac sodium channels. The drug shows efficacy with twice daily administration for adult patients. Approved and launched in Japan in 1991, it is currently indicated for the treatment of tachyarrhythmia (paroxysmal atrial fibrillation/flutter and ventricular tachycardia).

With this submission, Eisai hopes to establish an appropriate drug therapy to treat tachyarrhythmia in children, making greater contributions to the treatment of such patients.