FDA approves fast-acting heart drug for children
AOP Health, an Austrian pharmaceutical company, has secured U.S. Food and Drug Administration (FDA) approval for landiolol to be used for the treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in pediatric patients.
Landiolol, sold under the brand name Rapiblyk, is an adrenergic receptor blocker that acts fast. It is only meant be administered as an intravenous infusion in a hospital setting.
In 2024, the drug was approved for adults after the FDA reviewed data from multiple randomized trials. This update to cover patients of all ages was based on the LANDI-PED study, which included 60 pediatric patients presenting with SVT. Overall, treatment with landiolol was linked to a reduction in ventricular rate of more than 20%.
“With this expanded indication, Rapiblyk becomes available as a treatment option for pediatric patients with SVT in the U.S.,” John Kimmet, general manager of AOP Health U.S., said in a statement. “This milestone reflects our ongoing efforts to support healthcare professionals managing complex cardiovascular conditions in critical care settings.”
Landiolol is not recommended for patients with severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree, decompensated heart failure, cardiogenic shock or pulmonary hypertension. AOP Health emphasized that patients treated with landiolol should be monitored closely due to a small risk of bradycardia, including sinus pause, heart block, severe bradycardia and cardiac arrest. The most common adverse reaction is hypotension.
AOP Health’s full name is AOP Orphan Pharmaceuticals GmbH. The AOP Health Group is a larger collection of companies that includes multiple subsidiaries and offices throughout Europe and the Middle East.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.