VIENNA -- AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk™ (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that Rapiblyk™ (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time.

The approval was based on data of 5 randomized, double-blind, placebo-controlled studies. A total of 317 adults with supraventricular tachycardia were treated with landiolol: The heart rate decreased in 40-90% of treated patients within about 10 minutes, compared to 0-11% of patients who received placebo; heart rate decrease was defined as a >20% decrease in heart rate or a heart rate <100 bpm or at least intermittent cessation of the arrhythmia. In placebo-controlled clinical trials, adverse events were observed in 9,9% of landiolol treated patients vs. 1 % in patients treated with placebo.”

New Therapeutic option for rapid and “short-term” treatment of supraventricular tachycardia

AOP Health strives to offer solutions for patients with rare diseases or in critical care. Therefore, this approval marks an important moment for patients suffering from atrial fibrillation and atrial flutter in intensive care settings. “Rapiblyk™ approval in the US represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction. After being available in Europe, we are delighted that this therapeutic option can be now available also for US patients” says Dr. Martin Steinhart, CEO of AOP Health.

Study Design

Five randomized, double-blind, placebo-controlled studies were conducted to test landiolol efficacy and safety in patients with supraventricular tachycardia (including atrial fibrillation and atrial flutter). A total of 317 adults were treated with landiolol: heart rate in patients treated with landiolol decreased of 40-90% vs 0-11% of patients who received placebo. Heart rate decrease was defined as a >20% decrease in heart rate or a heart rate <100 bpm or at least intermittent cessation of the arrhythmia. The infused dose of landiolol in these studies ranged from 9.3 to 74.6 mcg/kg/min. Adverse events were observed in 9,9% of landiolol treated patients (main adverse event was hypotension) vs. 1 % in patients treated with placebo.”