The U.S. Food and Drug Administration (FDA) has granted approval to AOP Health's Rapiblyk (landiolol) for the short-term reduction of ventricular rate in adult patients with supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, within the critical care setting. This approval, announced on November 27, 2024, provides a new therapeutic option for managing rapid heart rates in acute care situations.
Rapiblyk is an ultra-short-acting beta-1 adrenergic receptor antagonist, administered intravenously, designed for rapid heart rate control in emergency and critical care environments. It is specifically indicated for short-term use and is not intended for chronic arrhythmia management.
Clinical Efficacy and Safety
The FDA's decision was supported by data from five randomized, double-blind, placebo-controlled clinical trials involving 317 adults with SVT. Results indicated that Rapiblyk achieved a heart rate reduction in 40-90% of treated patients within approximately 10 minutes, compared to 0-11% in the placebo group. Heart rate decrease was defined as a >20% decrease in heart rate or a heart rate <100 bpm or at least intermittent cessation of the arrhythmia.
The most common adverse event reported in the trials was hypotension, occurring in 9.9% of patients treated with Rapiblyk versus 1% in the placebo group. The infused dose of landiolol in these studies ranged from 9.3 to 74.6 mcg/kg/min.
Mechanism of Action and Intended Use
Landiolol, the active ingredient in Rapiblyk, selectively blocks beta-1 adrenergic receptors in the heart, reducing heart rate without significantly lowering blood pressure. This mechanism makes it suitable for patients in critical care who require rapid and precise heart rate management.
Dr. Martin Steinhart, CEO of AOP Health, stated, "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."
Contraindications and Warnings
Rapiblyk is contraindicated in patients with severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree, decompensated heart failure, cardiogenic shock, pulmonary hypertension, or hypersensitivity to landiolol or its inactive ingredients.
Warnings and precautions include the risk of hypotension, bradycardia, cardiac failure, reactive airways disease, and potential interactions with diabetes mellitus and hypoglycemia. The drug should be used with caution in patients with Prinzmetal’s angina, pheochromocytoma, peripheral circulatory disorders, and hyperthyroidism.
Supraventricular Tachycardia: A Critical Care Challenge
Supraventricular tachycardias, including atrial fibrillation and atrial flutter, can occur in individuals with or without underlying heart disease. These conditions can impair cardiac function, leading to acute cardiovascular problems that require immediate medical intervention.
Rapiblyk offers healthcare professionals a valuable tool for managing these potentially life-threatening cardiac events, providing a rapid-onset, short-acting treatment option for heart rate control in critical care settings.
