AOP Health US, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved RAPIBLYK® (landiolol) for use in pediatric patients (from birth to <18 years of age) with supraventricular tachycardia (SVT). This approval expands the availability of RAPIBLYK® beyond adults to patients of all ages in critical care settings and provides the first therapeutic option for pediatric patients with SVT in the US.
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SVT is a condition characterized by an abnormally fast heart rhythm, which can require rapid and controlled management, particularly in acute care environments. The FDA’s decision is supported by data from the LANDI-PED study, which was conducted in 60 pediatric patients and showed a reduction of over 20 percent in ventricular rate from baseline in appropriate patients with SVT. This demonstrated a clinically meaningful reduction in ventricular rate in this patient subgroup.
“With this expanded indication, RAPIBLYK® becomes available as a treatment option for pediatric patients with SVT in the U.S.,” said John Kimmet, General Manager of AOP Health US. “This milestone reflects our ongoing efforts to support healthcare professionals managing complex cardiovascular conditions in critical care settings.”
RAPIBLYK® is an ultra-short-acting, selective beta-1 adrenergic receptor blocker administered intravenously in a monitored hospital setting. Its pharmacological profile allows for rapid onset and offset of action, supporting controlled heart rate management.
This approval marks a significant step for AOP Health US as it continues to expand its presence in the United States and address unmet medical needs in cardiovascular care.
About Rapiblyk®
Rapiblyk® (landiolol) is an ultra-short-acting, selective beta-1 adrenergic receptor blocker indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia (SVT) or irregular rapid heart rate, including atrial fibrillation and atrial flutter, especially in perioperative, postoperative, or critical-care settings. Rapiblyk® provides rapid onset and offset of action, allowing clinicians to achieve precise, controlled rate management with a favorable hemodynamic profile.
The product is supplied as an intravenous infusion designed for use in a monitored hospital setting.
INDICATION
RAPIBLYK® (landiolol) for injection is a beta-adrenergic blocker indicated for the short-term reduction of ventricular rate in:
- Adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter
- Pediatric patients with supraventricular tachycardia
Important Safety Information
Contraindications
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
- Hypersensitivity to landiolol or any of the inactive ingredients
Warnings and Precautions
- Patients with hemodynamic compromise, hypovolemia, or receiving interacting medications are at increased risk of hypotension. Monitor blood pressure closely. Reduce or discontinue RAPIBLYK if hypotension occurs.
- Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest, may occur. Monitor heart rate and rhythm. Reduce or discontinue RAPIBLYK for bradyarrhythmia.
- Beta-blockers may cause depression of myocardial contractility and may precipitate heart failure or cardiogenic shock. At the first sign of impending cardiac failure, discontinue RAPIBLYK and initiate supportive therapy.
- Beta-blockers may exacerbate bronchospasm. Use caution in patients with reactive airway disease. Discontinue infusion if bronchospasm occurs.
- Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and may increase the risk for severe or prolonged hypoglycemia. Monitor blood glucose in patients with diabetes or those at risk.
- Infusion site reactions including pain, swelling, and erythema have occurred. Avoid infusions into small veins or through butterfly catheters. Use an alternative site if reactions develop.
- Abrupt discontinuation of beta-blocker therapy in patients with coronary artery disease may result in exacerbations of angina, myocardial infarction, or ventricular arrhythmias. Monitor for signs of myocardial ischemia when discontinuing RAPIBLYK.
- Beta-blockers may increase serum potassium. Monitor electrolytes during therapy, especially in patients with renal impairment.
- Beta-adrenergic blockade may mask clinical signs of hyperthyroidism. Abrupt withdrawal may precipitate thyroid storm.
- Patients at risk of anaphylaxis may be more reactive to allergen exposure and may be unresponsive to usual doses of epinephrine.
Adverse Reactions
The most common adverse reaction was hypotension in adults and pediatric patients.
Drug Interactions
- Avoid concomitant use with negative inotropes or medications that slow heart rate or cardiac conduction.
- Beta-adrenergic agonists may antagonize the effects of RAPIBLYK.
- Use caution with catecholamine-depleting drugs due to increased risk of hypotension or bradycardia.
About AOP Health
AOP Health Group is a global enterprise with roots in Austria and a mission to address unmet medical needs through innovative, science-driven therapies in cardiovascular and rare disease. Since 1996, the AOP Health Group has been recognized as a pioneer in developing integrated therapy solutions that combine deep scientific expertise with a strong commitment to patient and physician needs.
Building on this foundation, AOP Health US, LLC was established in 2025 to expand the company’s impact in the United States. The team is focused on introducing its 2024 US FDA approved product for use in the critical care setting, while building the infrastructure to support healthcare professionals and the patients they serve.
Rapiblyk® is a USPTO registered trademark of AOP Orphan Pharmaceuticals GmbH (Austria).
© 2026 AOP Health. All rights reserved.
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With this expanded indication, RAPIBLYK® becomes available as a treatment option for pediatric patients with SVT in the U.S.
Contacts
Ernest Poon, ernest.poon@aop-health.com, 301-275-3282
