FDA Approves Landiolol (Rapiblyk) for Rapid Heart Rate Reduction in Critical Care

Key Insights

• The FDA has approved landiolol (Rapiblyk) for short-term treatment of supraventricular tachycardia, including atrial fibrillation and atrial flutter, in critical care settings.
• Landiolol, an intravenous adrenergic receptor antagonist, demonstrated a heart rate decrease within 10 minutes in up to 90% of patients in clinical trials.
• The approval provides a new therapeutic option for rapid heart rate control in U.S. patients experiencing acute cardiac arrhythmias.

AOP Health, an Austrian pharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for landiolol, to be sold under the brand name Rapiblyk, for the treatment of supraventricular tachycardia, including atrial fibrillation (AFib) and atrial flutter, in critical care settings. This approval marks a significant advancement in the acute management of these common cardiac arrhythmias.

Clinical Efficacy and Safety

Landiolol is an intravenous adrenergic receptor antagonist designed for rapid action, making it suitable for short-term use in managing acute cardiac arrhythmias. The FDA's decision was supported by data from a series of randomized trials demonstrating its efficacy in reducing heart rate. Specifically, landiolol was associated with a decreased heart rate within 10 minutes in up to 90% of patients, compared to up to 11% of patients given a placebo. Researchers defined a heart rate decrease as any reduction of at least 20% in a patient’s heart rate, a heart rate lower than 100 bpm, or the intermittent cessation of the arrhythmia.

Mechanism of Action

As a rapidly acting intravenous adrenergic receptor antagonist, landiolol provides clinicians with a tool to quickly manage heart rate in patients experiencing supraventricular tachycardia. Its targeted action and short duration make it particularly useful in critical care scenarios where rapid heart rate control is essential.

Company Statement

"Rapiblyk approval in the United States represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction," said Martin Steinhart, CEO of AOP Health, in a prepared statement. "After being available in Europe, we are delighted that this therapeutic option can be now available also for U.S. patients."

Contraindications

Landiolol is not recommended for patients with severe sinus bradycardia, decompensated heart failure, cardiogenic shock, or pulmonary hypertension. These contraindications are important considerations for clinicians when determining the suitability of landiolol for individual patients.