The FDA has expanded the indication of landiolol (Rapiblyk; AOP Health US) injection to include pediatric patients with supraventricular tachycardia (SVT), marking a significant advancement in the management of acute arrhythmias in critical care settings. This decision builds upon the drug’s initial approval for adult patients and introduces a new therapeutic option for clinicians treating pediatric populations with rapid heart rate disturbances.1
“With this expanded indication, [landiolol] becomes available as a treatment option for pediatric patients with SVT in the US. This milestone reflects our ongoing efforts to support health care professionals managing complex cardiovascular conditions in critical care settings,” said John Kimmet, general manager of AOP Health US, in a news release.1
Understanding SVT and the Need for Pediatric Options
SVT is characterized by an abnormally rapid heart rhythm originating above the ventricles and can present acutely in pediatric patients, often requiring rapid intervention to prevent hemodynamic instability.1 Treatment options in children have historically been limited, frequently relying on extrapolation from adult data or off-label therapies. The availability of an FDA-approved, short-acting agent specifically indicated for pediatric use may help address this therapeutic gap.
Landiolol is an ultra-short-acting, highly β1-selective intravenous β-blocker that reduces heart rate by slowing atrioventricular nodal conduction while minimizing effects on blood pressure and myocardial contractility. Its rapid onset and short half-life (approximately 3-4 minutes) allow for precise titration and quick discontinuation if adverse effects occur.2
Clinical Evidence Supporting the Expanded Indication
The FDA’s decision was supported in part by data from the LANDI-PED study (EudraCT: 2015-001129-17), which evaluated landiolol in pediatric patients with SVT. In this study of 60 pediatric patients, treatment with landiolol resulted in a greater than 20% reduction in ventricular rate from baseline, demonstrating clinically meaningful heart rate control in this population.1,3
Additional evidence from published literature has also supported the use of landiolol in pediatric arrhythmias. Studies have shown that landiolol effectively restores normal sinus rhythm or achieves adequate heart rate control in a significant proportion of pediatric patients with SVT, with a favorable safety profile.3
Expanding the Role of Landiolol in Cardiovascular Care
Prior to this expanded indication, landiolol (Rapiblyk) was approved in the US for short-term reduction of ventricular rate in adults with SVT, including atrial fibrillation and atrial flutter.4 Internationally, the agent has been widely used for years in Europe and Japan for similar indications, further supporting its clinical utility.2
Implications for Pharmacists and Clinical Practice
The expanded pediatric indication for landiolol introduces new considerations for pharmacists involved in critical care and cardiology. Pharmacists play a key role in dosing, monitoring, and ensuring safe administration of intravenous antiarrhythmic agents, particularly in pediatric populations where weight-based dosing and physiologic variability must be carefully managed.
As landiolol becomes more widely adopted in pediatric settings, pharmacists will be integral in educating interdisciplinary teams on its appropriate use, monitoring for adverse effects such as bradycardia or hypotension, and optimizing therapy for individual patients.
The FDA’s expansion of landiolol (Rapiblyk) to include pediatric patients with SVT represents an important step forward in addressing unmet needs in pediatric arrhythmia management. Supported by clinical trial data and a favorable pharmacologic profile, landiolol offers clinicians a rapidly titratable, short-acting option for acute heart rate control. As use expands, pharmacists will play a central role in ensuring safe and effective integration of this therapy into pediatric cardiovascular care.
REFERENCES
Rapiblyk (landiolol) is available for Pediatric Patients with SVT. AOP Health. Published April 15, 2026. Accessed April 15, 2026.
https://www.aop-health.com/us_en/press/press-releases/fda-approval-rapiblyk-pediatric/ Summary Review of Landiolol. Center for Drug Evaluation and Research. Application Number: 217202Orig1s000. Accessed April 15, 2026.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217202Orig1s000SumR.pdf 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). Europace. 2025;27(2):euaf025. doi:10.1093/europace/euaf025
Rapiblyk for Injection, 280 mg/vial. Center for Drug Evaluation and Research. Application Number: 217202Orig1s000. Accessed April 15, 2026.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217202Orig1s000Approv.pdf
