NDA Submitted for Landiolol, a Highly Cardioselective Beta Blocker

The New Drug Application (NDA) for landiolol has been submitted to the Food and Drug Administration (FDA) for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.

Landiolol is an ultra-short acting, intravenous, cardioselective, beta-1 adrenoceptor blocker that reduces heart rate with a minimal effect over cardiac contractility. The investigational treatment is designed for use in emergency, critical care, and operating room settings. With a β1:β2 ratio of 255:1, landiolol displays very high cardioselectivity, which is expected to lessen the impact on respiratory function.

Landiolol is currently commercially available in Japan and several European markets. There are multiple clinical studies conducted in these countries that have shown landiolol to be effective and safe for the rapid short-term control of tachyarrhythmias. The NDA submission includes summaries of pre-existing safety and efficacy data, along with a meta-analysis of published randomized controlled trials; the FDA deemed these datasets be adequate to support the application.

“We believe that landiolol has the potential to become a cornerstone therapy in the management of tachycardia in critically ill patients,” said Scott Tarriff, President and CEO of Eagle Pharmaceuticals. “Landiolol has differentiated clinical characteristics and an established safety profile, and we look forward to working with FDA during the course of the review process.”

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