The FDA has approved landiolol for rapid heart rate management in critical care settings, offering a new treatment option for atrial fibrillation, atrial flutter, and other supraventricular tachycardia.
Summary: The FDA has approved landiolol (brand name Rapiblyk) for use in critical care settings to treat supraventricular tachycardias, including AFib and atrial flutter. This approval is based on clinical studies showing that landiolol enables rapid heart rate management with minimal impact on blood pressure. The drug offers a new treatment option for patients requiring immediate intervention for these arrhythmias.
Key Takeaways:
- Rapid and Effective Treatment: Landiolol was shown to reduce heart rate in 40-90% of patients within 10 minutes, providing a fast-acting option for managing atrial fibrillation and atrial flutter in critical care.
- Safety Profile: In clinical trials, adverse events were observed in 9.9% of patients treated with landiolol, compared to 1% in those given a placebo.
- New Option for US Patients: Already available in Europe, landiolol’s approval in the US expands the therapeutic choices for managing supraventricular tachycardias in hospital critical care settings.
The US Food and Drug Administration (FDA) has granted regulatory approval for landiolol in the hospital critical care setting for the treatment of supraventricular tachycardias (including atrial fibrillation and atrial flutter).
Supraventricular tachycardias can occur both in patients with and without heart disease. Because they can impair cardiac function, leading to acute cardiovascular problems, they require immediate medical attention.
The approval is based on clinical studies that demonstrated that landiolol (brand name Rapiblyk, AOP Orphan Pharmaceuticals) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the US with a new treatment option.
“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 Martin Steinhart, MD, CEO of AOP Health, in a release.
The approval was based on data of five 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.
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