This application is based on the results of a multi-center, open-label, single-arm, late Phase / study in pediatric patients with tachyarrhythmia accompanied by low cardiac function (ONO-1101-31).
In case of low cardiac function with unstable hemodynamics, such as after open-heart surgery for congenital heart diseases in pediatric patients, if tachyarrhythmia persists, it may be potentially serious or fatal. Therefore, the treatment for tachyarrhythmia is immediately required. Since non-drug treatment such as catheter ablation may be sometimes difficult in pediatric patients depending on their physique and age, drug treatment is an important and main treatment method. However, there are a few antiarrhythmic drugs approved for pediatric indications and treatment options are limited in
ONOACT is a short-acting selective ?1 blocker that reduces heart rate by selectively blocking ?1 receptor which is present predominantly in the heart. ONOACT has already been approved for the treatment of tachyarrhythmia in adult patients with low cardiac function. In the results of this pediatric study, it was shown that ONOACT also lowered heart rate rapidly without reducing cardiac function. Therefore, ONOACT is expected to contribute to the treatment of tachyarrhythmia in pediatric patients with low cardiac function.
ONO received an approval of ONOACT for emergency treatment of intra-operative tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) in adult patients in
Emergency measurement of post-operative tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) occurring under the monitoring of circulatory dynamics (
Tachyarrhythmia (atrial fibrillation and atrial flutter) in low cardiac function (
Life-threatening arrhythmia (ventricular fibrillation and hemodynamically unstable ventricular tachycardia) that is refractory and needs emergency measurement (
Tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) associated with sepsis (
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