Tuesday, February 19, 2013

ONO Pharmaceutcal files for approval of Additional Indication for Onoact® 50 injection, Short-Acting Selective β1 Blocker in Japan

Ono Pharmaceutical Co Ltd. announced today that an application for treatment of tachyarrhythmia (atrial fibrillation (AF) and atrial flutter (AFL)) in left ventricular (LV) dysfunction has been filed as an
additional indication to the short-acting selective β1 blocker injection drug Onoact® 50 for injection (landiolol) in Japan. Tachyarrhythmia (AF/AFL) is a form of arrhythmia which occurs with a high incidence in patients with LV dysfunction (heart failure) including cardiomyopathy and coronary artery
disease. AF/AFL with LV dysfunction accompanying by persistent elevated heart rate would lead to further deterioration of cardiac performance. Swift rate control is inevitable to be restored from this detrimental condition, however, no drug on market can provide both the features of fast-acting and easy titratability for tachyarrhythmia (AF/AFL) with LV dysfunction.
Onoact® 50 for injection is the short-acting selective β1 blocker which reduces heart rate by selectively blocking β1 receptors located chiefly in the heart and this fast-acting drug can be easily titrated. We expect that Onoact® 50 for injection can contribute to promptly reducing heart rate without causing deterioration of cardiac performance in treatment of tachyarrhythmia (AF/AFL) with LV dysfunction.
This short-acting selective β1 blocker drug is discovered and developed by ONO and has been widely used by many patients since its launch. The drug has firstly received approval for emergency treatment of intra-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) in July 2002. Then, it had also been approved for additional indication of emergency treatment of post-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) with monitoring of circulatory dynamics in October 2006.

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