AOP Health US Marks First Patient Treated with Rapiblyk® in the United States, Expanding Access to Critical Care Innovation Nationwide

WILMINGTON, Del.--(BUSINESS WIRE)--AOP Health US, LLC today announced that the first patient in the United States has been treated with Rapiblyk® (landiolol) at The Valley Hospital, Paramus, NJ. This marks a key milestone in the company’s U.S. expansion and its efforts to address high unmet medical needs in critical care. AOP Health US is now positioned on a national stage to support clinicians and care teams with an innovative therapeutic option for patients with acute cardiac arrhythmias.

“This milestone represents an important step forward in improving access to innovative therapies for patients and the clinicians who treat them,” said John Kimmet, General Manager of AOP Health US. “Bringing Rapiblyk® into clinical practice in the U.S. enables us to support critical care teams with a fast-acting treatment option and reflects our commitment to addressing unmet medical needs.”

Rapiblyk® (landiolol) is an ultra-short-acting, highly selective beta-1 adrenergic receptor blocker designed for rapid and controlled heart rate management. It is administered intravenously in a monitored hospital setting, particularly in critical care environments.

Therapy Approved for All Ages

Landiolol received U.S. Food and Drug Administration (FDA) approval in November 2024 and was previously approved for use in Europe, Japan, and Canada. The therapy is approved for all ages and is used to treat abnormal heart rhythms such as atrial fibrillation and atrial flutter.

“Cardiac critical care teams require fast, precise tools to stabilize patients with complex and life-threatening conditions,” said Yonathan Litwok, MD, Director of Cardiac Critical Care at The Valley Hospital. “Having access to new treatment options supports our ability to provide high-quality, responsive care to patients in critical situations.”

Cardiac critical care is a specialized field focused on patients with severe or unstable cardiovascular conditions requiring continuous monitoring, advanced therapies, and rapid intervention. Effective management in these settings depends on coordinated, team-based care and timely therapeutic options.

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.

For more information about RAPIBLYK, see Full Prescribing Information

About AOP Health

AOP Health 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).

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