FDA Approves Landiolol For Treatment of Supraventricular Tachycardia

Updated on November 27 at 11:30 am.

The FDA approved landiolol (Rapiblyk; AOP Orphan Pharmaceuticals GmbH) for use in hospital critical care settings for the treatment of supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies that demonstrate the management of heart rate with minimal reductions to blood pressure.¹

“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,” said Martin Steinhart, CEO of AOP Health, in a news release.¹

Supraventricular tachycardia is a type of irregular heartbeat classified by fast or erratic beats that affect the upper chambers of the heart, according to the Mayo Clinic. The typical heart beats about 60 to 100 times per minutes, but with supraventricular tachycardia, the heart can beat between 150 to 220 times a minute. It is usually not life-threatening unless there is heart damage or another heart condition. However, if severe, it can cause sudden cardiac arrest, according to the Mayo Clinic.²

The approval was based on data from 5 randomized, double-blind, and placebo-controlled studies that included a total of 317 adults with supraventricular tachycardia, according to the company. In the trial, investigators found that, when treated with landiolol, patient’s heart rate decreased by 40% to 90% within 10 minutes compared with 0% to 11% for those treated with the placebo. Heart rate decrease was defined as a greater than 20% decrease in heart rate, a heart rate of less than 100 beats per minute, or at least intermittent cessation of the arrhythmia. The investigators also reported that adverse events were observed in 9.9% of those treated with landiolol and 1% of those treated with the placebo.¹

In another study, investigators reviewed data from patients with sepsis who were admitted to an intensive care unit between January 2006 and December 2011, including 61 individuals who experienced supraventricular tachycardia. Of those patients, 39 were treated with landiolol and 22 were not. Investigators compared the arterial pressure, heart rate, cardiac rhythm, pulmonary arterial pressure, and cardiac output between the 2 groups at 1, 8, and 24 hours after supraventricular tachycardia. According to the results the initial dose of landiolol administered was 6.3 ± 5.8 g/kg per minute, which reduced heart rate without any deterioration of hemodynamics. Heart rate decreased from about 145 bpm to 90 bpm for landiolol compared with control group from 136 bpm to 109 bpm.³

This study was the first to report the clinical usage of landiolol for treating supraventricular tachycardia in patients with severe sepsis. Investigators concluded that the drug safely reduced heart rate and converted heart rate to a sinus rhythm, according to the study authors.³

REFERENCES

1. U.S. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting. News release. AOP Health. November 27, 2024. Accessed November 27, 2024. https://www.businesswire.com/news/home/20241127506170/en/U.S.-FDA-Approves-AOP-Health%E2%80%99s-RapiblykTM-landiolol-for-Atrial-Fibrillation-and-Atrial-Flutter-in-the-Critical-Care-Setting

2. Mayo Clinic. Supraventricular tachycardia. Updated March 7, 2024. Accessed November 27, 2024. https://www.mayoclinic.org/diseases-conditions/supraventricular-tachycardia/symptoms-causes/syc-20355243

3. Nasoufidou A, Papazoglou AS, Stachteas P, et al. Intravenous Landiolol for Rate Control in Supraventricular Tachyarrhythmias in Patients with Left Ventricular Dysfunction: A Systematic Review and Meta-Analysis. J Clin Med. 2024;13(6):1683. Published 2024 Mar 14. doi:10.3390/jcm13061683