MHLW grants additional approval for Onoact for tachyarrhythmia in pediatric patients.- Ono Pharma
Ono Pharmaceutical Co., Ltd. announced that ONO received an approval of Onoact (generic name: landiolol hydrochloride) for Intravenous Infusion 50mg/150mg , a short-acting selective beta 1 blocker in Japan for additional indication of tachyarrhythmia (supraventricular tachycardia, atrial fibrillation and atrial flutter) in pediatric patients with low cardiac function for a partial change in the approved items of the manufacturing and marketing approval.
This approval is based on the results of a multi-center, open-label, uncontrolled late Phase III study (Heartful study: ONO-1101-31) conducted in Japan in pediatric patients with tachyarrhythmia accompanied by low cardiac function. In this study, the percent of patients with a reduction in heart rate 1 greater than 20% from the initial rate of tachycardia or termination of tachycardia at 2 hours after starting Onoact, the primary endpoint, was 48.0% (12/25 patients). The safety profile of Onoact in this study was consistent with that observed in studies of approved indications, and no new safety concerns were observed.
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