Eisai has received approval of an additional indication of anti-arrhythmic agent Tambocor 50mg, 100mg Tablets (flecainide acetate) for the treatment of tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular tachycardia, ventricular tachycardia) in pediatric patients in Japan.
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Eisai said that as there are currently few anti-arrhythmic agents with limited indications approved for pediatric use in Japan, arrhythmia has represented an area of unmet medical need in the pediatric care.
Eisai claimed that with Tambocor already approved for the treatment of tachyarrhythmia in children in the US, and its clinical usefulness reported in medical literature, the Japanese Ministry of Health, Labour and Welfare’s Council for Pediatric Pharmacotherapy determined the need to make the drug available to treat pediatric patients in Japan.
Reportedly, Tambocor tablets are expected to provide a new drug treatment option to those patients who due to age or body size have difficulty using catheter treatments or who do not respond to currently marketed anti-arrhythmic drugs. Furthermore, Eisai stated that Tambocor is expected to be the first drug in Japan to be indicated for the treatment of ventricular tachycardia in pediatric patients.
Eisai stated that Tambocor tablets suppress tachyarrythmia by blocking cardiac sodium channels and slowing down cardiac conduction. Approved and launched in Japan in 1991, the drug has until now been indicated for the treatment of tachyarrythmia in adults.
By offering Tambocor tablets as a new treatment option, Eisai is now expected to be able to provide pediatric patients with tachyarrythmia with an appropriate new drug therapy.
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