The FDA has approved Rapiblyk (landiolol), an ultra-short-acting beta-blocker, for the short-term treatment of supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, in adult critical care patients. This approval is based on five clinical trials demonstrating Rapiblyk’s ability to rapidly control heart rate with minimal blood pressure reduction. The approval provides a new treatment option for SVT in the US and marks AOP Health’s first entry into the US market.
For patients experiencing SVT in critical care settings, Rapiblyk offers a much-needed treatment option for rapid heart rate control, potentially improving outcomes. For AOP Health, the FDA approval signifies a major milestone, expanding its reach into the US and bolstering its portfolio in critical care. The approval also addresses an unmet need in the critical care setting for a rapid and short-acting treatment for SVT. This provides healthcare professionals with a valuable tool for managing these potentially life-threatening cardiac events.
In clinical trials involving 317 adults with SVT, Rapiblyk achieved a 40-90% heart rate reduction within approximately 10 minutes compared to 0-11% in the placebo group. 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 most common adverse event was hypotension, occurring in 9.9% of patients treated with Rapiblyk versus 1% in the placebo group. The drug is administered intravenously and is specifically designed for short-term use in critical care situations. It is not intended for chronic arrhythmia management. Rapiblyk’s FDA approval has the potential to reshape the treatment landscape for SVT in critical care. The drug’s rapid onset and short duration of action offer a precise and controlled approach to heart rate management in acute settings. This targeted approach could lead to improved patient outcomes and potentially reduce the need for more invasive interventions. The availability of a new, effective treatment option may also prompt further research and innovation in the field of critical care cardiology. Furthermore, AOP Health’s entry into the US market could stimulate competition and drive the development of even more refined therapies for SVT and other critical care conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
