FDA approves Rapiblyk (landiolol) to treat 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.”