FDA approves new short term treatment for Afib atrial flutter in critical care settings
Austrian pharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for landiolol to be used in a critical care setting for the treatment of supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Landiolol, which will be sold under the brand name Rapiblyk, is an intravenous adrenergic receptor antagonist that acts fast; it is not intended to be taken for long periods of time to treat chronic cardiac arrhythmias.
The FDA’s decision was based on data from a series of randomized trials. Overall, landiolol was associated with a decreased heart rate within 10 minutes in up to 90% of patients compared to up to 11% of patients given a placebo. Researchers defined a heart rate decrease as any reduction of at least 20% in a patient’s heart rate, a heart rate lower than 100 bpm or the intermittent cessation of the arrhythmia.
“Rapiblyk approval in the United States represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction,” Martin Steinhart, CEO of AOP Health, said in a prepared statement. “After being available in Europe, we are delighted that this therapeutic option can be now available also for U.S. patients.”
Landiolol is not recommended for patients with severe sinus bradycardia, decompensated heart failure, cardiogenic shock or pulmonary hypertension.
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.
landiolol, is an injectable drug that slows the heart rate by blocking adrenaline’s action on beta-1 receptors in the heart. Its precise, short-term effect makes it good for quickly lowering heart rate with minimal impact on blood pressure and other body functions.
landiolol, is an injectable drug that slows the heart rate by blocking adrenaline’s action on beta-1 receptors in the heart. Its precise, short-term effect makes it good for quickly lowering heart rate with minimal impact on blood pressure and other body functions.
Esmolol and landiolol are 2 drugs that act by specifically blocking the β-adrenergic cardiac receptor with an ultra-short duration of action. These 2 characteristics make them attractive for multiple applications in several clinical fields. β-blockers can be used to prevent or treat arrhythmias and myocardial ischemia in cardiac and noncardiac surgery as cardioplegia adjuvants or to test the reversibility of SAM in cardiac surgery, for medical treatment of aortic dissection before surgery, to improve microcirculation in critically ill patients with sepsis and arterial oxygenation during ECMO, to decrease the possibility of hemodynamic deterioration during intubation, and to improve the quality of the image in coronary CT angiography. However, for most of these uses, evidence is scarce and future studies are needed. Administer as a continuous IV infusion, titrating as needed for heart rate control; data are limited beyond 24 hours of use.
The FDA’s decision was based on data from a series of randomized trials. Overall, landiolol was associated with a decreased heart rate within 10 minutes in up to 90% of patients compared to up to 11% of patients given a placebo. Researchers defined a heart rate decrease as any reduction of at least 20% in a patient’s heart rate, a heart rate lower than 100 bpm or the intermittent cessation of the arrhythmia.
