AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, has announced that the U.S. Food and Drug Administration (FDA) has approved Rapiblyk™ (landiolol) for the treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in critical care settings. This approval provides a new treatment option for patients in the United States who are dealing with these serious heart conditions, marking a significant milestone in AOP Health’s mission to address rare diseases and intensive care needs.
The approval is based on data from five randomized, double-blind, placebo-controlled clinical studies that involved 317 adult patients with SVT. The studies showed that Rapiblyk™ was effective in rapidly regulating heart rates, with a significant reduction observed in 40-90% of patients treated with the drug. The reduction in heart rate occurred within approximately 10 minutes, while only 0-11% of patients in the placebo group experienced a similar response. A reduction in heart rate was defined as a decrease of over 20% or a heart rate less than 100 beats per minute (bpm), or at least a temporary cessation of arrhythmia. The studies also showed that side effects occurred in 9.9% of patients treated with Rapiblyk™ compared to just 1% in the placebo group, with hypotension being the most common adverse reaction.
Dr. Martin Steinhart, CEO of AOP Health, emphasized the significance of the approval, stating, “This approval is an important milestone for patients who suffer from supraventricular tachycardia, including atrial fibrillation and atrial flutter, and who require a rapid and short-term reduction in heart rate. We are very pleased that this treatment option, which is already available in Europe, is now also available to patients in the U.S.”
Rapiblyk™ is an ultra-short-acting adrenergic receptor antagonist with a beta-1/beta-2 selectivity ratio of 255. It is designed to act quickly in emergency situations, effectively lowering heart rate without significantly impacting blood pressure. This makes it particularly suitable for use in critical care units, during cardiac emergencies, or in operating rooms, but it is not meant for the long-term treatment of chronic arrhythmias. Rapiblyk™ is used in intensive care settings for the short-term treatment of SVT, including atrial fibrillation and atrial flutter, and for non-compensatory sinus tachycardia.
The indication for Rapiblyk™ includes short-term use to reduce ventricular rate in adults with SVT. While the drug is highly effective in managing heart rates in emergency situations, there are certain safety considerations. Rapiblyk™ is contraindicated in patients with severe sinus bradycardia, sick sinus syndrome, heart block greater than 1st degree, decompensated heart failure, and those with cardiogenic shock. Additionally, it should not be used in patients with pulmonary hypertension, hypersensitivity reactions, or in those with certain conditions like diabetes or bronchospasm. The most common side effect observed is hypotension, occurring in 9.9% of patients.
Landiolol’s role in the treatment of supraventricular tachycardia is vital due to the nature of the condition. Supraventricular tachycardia, including atrial fibrillation and atrial flutter, can occur in individuals with or without existing heart disease. These arrhythmias can impair heart function and cause acute cardiovascular issues, necessitating immediate medical intervention.
This approval represents a significant expansion for AOP Health, a company that has long been dedicated to advancing healthcare solutions for patients with rare diseases and critical care needs. AOP Health has built a solid reputation as a pioneer in integrated therapies for rare diseases and intensive care, with a strong commitment to research and development. The company’s motto, “Needs. Science. Trust,” reflects its commitment to addressing the most urgent medical needs of patients while delivering effective and innovative treatments.
In conclusion, the FDA’s approval of Rapiblyk™ marks a major step forward in the management of supraventricular tachycardia, providing a much-needed treatment option for patients in critical care. With this approval, AOP Health continues to fulfill its mission to improve the lives of patients dealing with serious heart conditions and rare diseases, extending its reach from Europe to the U.S. and beyond.
