FDA

FDA approves short-acting beta-blocker

December 3, 2024

Brand name: Rapiblyk

Generic name: landiolol

Manufacturer: AOP Health

Approval date: November 22, 2024

Rapiblyk (landiolol) is an ultra-short-acting, beta-1 selective adrenergic receptor antagonist that’s indicated for use in the hospital critical care setting for the treatment of supraventricular tachycardia (SVT; afib and atrial flutter).

According to a manufacturer press release, landiolol is characterized by a fast onset of action and rapid reduction in heart rate without significantly lowering BP.

Efficacy

Approval was based on data from 5 randomized, double-blind, placebo-controlled trials involving 317 adults with SVT who were treated with landiolol. Heart rate decrease (defined as a >20% decrease in heart rate or heart rate <100 bpm or at least intermittent cessation of the arrhythmia) occurred in 40% to 90% of landiolol-treated patients within about 10 minutes, vs. 0 to 11% of those who received placebo.

Safety

The most common adverse reaction reported in clinical trials was hypotension (9.9%).

Recommended dose

Rapiblyk is administered as a continuous IV infusion in a monitored setting, titrated to ventricular rate.

Sources:

AOP Health. (2024, November 27). U.S. FDA approves AOP Health’s Rapiblyk™ (landiolol) for Atrial Fibrillation and Atrial Flutter in the critical care setting. [Press release]. https://www.aop-health.com/global_en/press/press-releases/us-fda-approves-rapiblyk/

AOP Health: Rapiblyk (landiolol) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217202s000lbl.pdf