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Find Clinical Drug Pipeline Developments & Deals for Landiolol Hydrochloride
Submission seeks approval for LDLL600 (landiolol) for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Health that has a selective effect on heart rate over cardiac contractility.
The Company will support the submission of a new drug application to the U.S. FDA seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
This approval is based on the result of a multi-center, randomized, open-label, parallel-group, late Phase Ⅱ / Ⅲ study (J-Land 3S study: ONO-1101-32) conducted in Japan, in patients with tachyarrhythmia associated with sepsis.