Rapiblyk (Landiolol): A New Fast-Acting Option for AFib in the ICU

The US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings. These conditions, collectively known as supraventricular tachycardias, involve the heart beating too fast or irregularly, leading to acute complications. This approval marks Rapiblyk’s introduction to the US market after being available in Europe.

Rapiblyk is to be administered as a continuous intravenous (IV) infusion and intended for short-term use, typically not exceeding 24 hours.

Landiolol is a selective beta-1 adrenergic receptor antagonist, designed to reduce heart rate swiftly without causing a significant drop in blood pressure — a critical advantage for managing arrhythmias in emergency and intensive care settings. It minimizes the effects on beta-2 receptors, reducing the risk of respiratory complications such as bronchospasm, which are common with non-selective beta-blockers.

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According to the American Heart Association, managing ventricular rates in critically ill patients is crucial to prevent hemodynamic compromise — a condition where the heart struggles to pump enough blood to supply oxygen and nutrients to vital organs. If untreated, this can result in low blood pressure, diminished cardiac output and inadequate organ function.

Additionally, landiolol’s ultra-short elimination half-life of approximately four minutes ensures rapid adjustment and reversibility of its effects. This feature differentiates it from other beta-blockers like esmolol, with a nine-minute half-life, and metoprolol, which has a half-life of three to seven hours, both of which have longer durations of action.

Dr. Martin Steinhart, CEO of AOP Health, emphasized the significance of this approval, calling it a milestone for patients needing rapid heart rate control in critical care environments. He expressed optimism about the therapy’s potential to enhance outcomes for patients in the US.

The approval is grounded in data from five randomized, double-blind, placebo-controlled trials involving 317 adults. These studies revealed that 40 to 90 percent of participants treated with landiolol achieved at least a 20 percent reduction in heart rate or intermittent cessation of arrhythmia within ten minutes of administration, compared to just zero to 11 percent in the placebo group.

The dosing, ranging from 9 to 36 mcg/kg/min, was adjusted in 10-minute intervals for patients with normal cardiac function and 15-minute intervals for those with impaired function. Hypotension, the most common adverse event, occurred in 9.9 percent of patients, underscoring the importance of close monitoring during use.

With this approval, AOP Health hopes to better manage critical arrhythmias with a faster, safer option for patients in need of urgent care.