Austria-based AOP Orphan Pharmaceuticals, part of AOP Health, has received approval from the US Food and Drug Administration (FDA) for Rapiblyk (landiolol) to treat supraventricular tachycardia.
The approval covers its use for managing atrial fibrillation and atrial flutter, specifically in hospital critical care settings.
It is supported by clinical trial data demonstrating landiolol’s ability to achieve rapid heart rate control while maintaining stable blood pressure. This marks AOP Health’s entry into the US market, expanding its critical care portfolio to meet urgent medical needs.
Landiolol, an ultra-short-acting adrenergic receptor antagonist with a beta-1/beta-2 selectivity ratio of 255, is intended for use in emergency and short-term critical care scenarios.
According to AOP Health, landiolol’s fast onset of action and heart rate reduction capabilities make it suitable for environments such as cardiac critical care units, operating theatres, and intensive care units.
It is not intended for long-term management of chronic arrhythmias. In Europe, the drug is already approved for supraventricular tachycardia and for managing non-compensatory sinus tachycardia.
AOP Health CEO Martin Steinhart said: “Rapiblyk approval in the US represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction.
“After being available in Europe, we are delighted that this therapeutic option can be now available also for US patients.”
The FDA approval is based on results from five randomised, double-blind, placebo-controlled studies involving 317 adult patients with supraventricular tachycardia.
The findings revealed that 40–90% of patients treated with landiolol experienced significant heart rate reduction within approximately 10 minutes, compared to 0–11% in the placebo group.
Heart rate control was defined by a reduction of over 20%, a rate of fewer than 100 beats per minute, or intermittent cessation of arrhythmia.
Adverse events, primarily hypotension, were observed in 9.9% of patients treated with landiolol, compared to 1% in the placebo group. The dosing in the studies ranged from 9.3 to 74.6 micrograms per kilogram per minute.
