FDA approves landiolol for pediatric supraventricular tachycardia

The FDA has approved landiolol (Rapiblyk; AOP Health US) for use in individuals younger than 18 years with supraventricular tachycardia (SVT), providing the first therapeutic option for pediatric patients with SVT in the United States.¹

This approval is based on positive results from the LANDI-PED study. The data indicated a reduction in ventricular rate of greater than 20% in patients taking landiolol, which is considered clinically meaningful. With this approval, the availability of landiolol is expanded beyond adult patients to reach those of all ages.

“With this expanded indication, Rapiblyk becomes available as a treatment option for pediatric patients with SVT in the [United States],” said John Kimmet, General Manager of AOP Health US.

Mechanism of action and contraindications

Landiolol is an ultra-short-acting selective beta-1 adrenergic receptor blocker designed to reduce short-term ventricular rates or irregular rapid heart rates in SVT patients. This is especially useful in perioperative, postoperative, or critical-care settings.

By providing rapid onset, clinicians can use landiolol to help their patients reach a precise, controlled ventricular rate and a favorable hemodynamic profile. The therapy is designed for intravenous administration at an in-hospital setting. Contraindications of landiolol include the following:

• Severe sinus bradycardia
• Sick sinus syndrome
• Heart block greater than first degree
• Decompensated heart failure
• Cardiogenic shock
• Pulmonary hypertension
• Hypersensitivity to landiolol or any of the inactive ingredients

Experts have also warned that the risk of hypotension is greater in patients with compromise or hypovolemia receiving landiolol. Therefore, blood pressure should be closely monitored in these patients, and treatment should be discontinued in the event of hypotension.

Additionally, heart rate and rhythm should be monitored for the risk of bradycardia, with treatment reduced or discontinued if bradyarrhythmia occurs. Heart failure or cardiogenic shock may also occur in patients taking beta-blockers, necessitating discontinuation of the therapy and initiation of supportive therapy.

LANDI-PED study outcomes

The LANDI-PED study included 60 patients, 9 of whom discontinued treatment prematurely.² Among these patients, 90% had underlying cardiac disease and 40% reported cardiac surgery within the week before treatment with landiolol. While 17 were not undergoing surgery, 14 were in the perioperative period and 29 in the postoperative period.

Twenty-five percent of patients achieved normal sinus rhythm (NSR) conversion within 210 minutes of landiolol infusion, which was reported as the study’s primary outcome. Additionally, 17 patients met the criteria for entering the prolongation phase, 8 of whom achieved NSR conversion during subsequent landiolol infusion.

This led to normal sinus rhythm in 38.3% of patients overall by the end of landiolol infusion. A heart rate reduction of at least 20% was reported in 51.7% overall, with the general reduction in heart rate being significant.

Safety results were also positive, with only 6 of the 46 adverse events reported being linked to the drug. All of these were cases of hypotension, and 3 were also linked to the underlying SVT. Recovery was reported in all cases after discontinuation or dose reduction of landiolol.

Overall, the data indicated safety and efficacy from landiolol use in pediatric patients. Investigators concluded that children can be treated with a similar dosing regimen as adults.

“To further refine the therapeutic strategies, more studies are required to complement the existing evidence on the optimal use of pharmacological treatments of SVTs in the pediatric population,” wrote investigators.

References

1. AOP Health US LLC: RAPIBLYK (landiolol) approved by FDA for use in pediatric patients with supraventricular tachycardia. News release. AOP Health US. April 15, 2026. Accessed April 15, 2026. https://www.businesswire.com/news/home/20260415402673/en/AOP-Health-US-LLC-RAPIBLYK-landiolol-Approved-by-FDA-for-Use-in-Pediatric-Patients-with-Supraventricular-Tachycardia
2. Michel-Behnke I, Müller M, Stiller B, et al. Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED). EP Europace. 2025;27(2):euaf025. doi:10.1093/europace/euaf025