FDA Approves AOP Health’s Rapiblyk for Atrial Fibrillation and Atrial Flutter

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The FDA has approved AOP Health’s Rapiblyk (landiolol) for the rapid management of atrial fibrillation and atrial flutter in critical care settings. According to the company, approval was based on results five different studies in adults with supraventricular tachycardia. AOP Health stated that this approval aligns with its mission to provide innovative solutions for rare diseases and critical care, expanding access to European-approved therapies for patients in the United States.¹

“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,” said Martin Steinhart, CEO, AOP Health, in a press release.

The five studies were double-blind, placebo-controlled studies aimed at testing the efficacy and safety of Rapiblyk in patients with supraventricular tachycardia (including atrial fibrillation and atrial flutter). Consisting of 317 patients, results found that heart rate in patients treated with Rapiblyk decreased in ranges of 40% to 90% compared to 0% to 11% for patients treated with a placebo. Heart rate was decrease was defined as a >20% decrease in heart rate or a heart rate <100 bpm or at least intermittent cessation of the arrhythmia.

Adverse events (AEs) were found in 9,9% of patients treated with Rapiblyk and 1% in patients treated with placebo, while most common AE was hypertension. AOP Health warns that the treatment is contraindicated in patients with severe sinus bradycardia; sick sinus syndrome; heart block greater than first degree; decompensated heart failure; cardiogenic shock; pulmonary hypertension; and hypersensitivity reactions, such as anaphylaxis to any of the inactive ingredients to landiolol.¹

According to the Mayo Clinic, the heart beats about 150 to 220 times a minute as a result of supraventricular tachycardia. The three most common types include atrioventricular nodal reentrant tachycardia, atrioventricular reciprocating tachycardia, which is most commonly found in younger people, and atrial tachycardia, which is commonly found in people with heart disease and doesn’t include the AV node. Additional forms of supraventricular tachycardia include sinus nodal reentrant tachycardia, inappropriate sinus tachycardia, multifocal atrial tachycardia, junctional ectopic tachycardia, and nonparoxysmal junctional tachycardia.²

The estimated prevalence of supraventricular tachycardia is 2.25 per every 1,000 people, with women having a two times greater risk of developing it than men. Patients over 65 years of age have more than five times the risk of developing supraventricular tachycardia than any other age group. Further, a pediatric study indicated that between 2000 and 2008, people born with the condition had an annual risk of sudden death of 0.01% by 15 years of age. Globally, the prevalence of a pattern ranges from 0.15-0.25%, increasing to 0.55% among first-degree relatives of affected patients.³

Medscape estimates that paroxysmal paroxysmal supraventricular tachycardia is approximately 1-3 cases per 1000 persons, with a prevalence of 0.2%. Atrial fibrillation affects approximately three million people in the United States, with estimates predicting that it will affect more than 7.5 million people by 2050. While it can be observed in health individuals, it is also found in patients with previous myocardial infarction, mitral valve prolapses, rheumatic heart disease, pericarditis, pneumonia, chronic lung disease, and current alcohol intoxication. Additionally, digoxin toxicity also may be associated with paroxysmal supraventricular tachycardia.⁴

References

1. U.S. FDA Approves AOP Health’s RapiblykTM (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting. Business Wire. November 27, 2024. Accessed November 27, 2024. https://www.businesswire.com/news/home/20241127506170/en/U.S.-FDA-Approves-AOP-Health%E2%80%99s-RapiblykTM-landiolol-for-Atrial-Fibrillation-and-Atrial-Flutter-in-the-Critical-Care-Setting

2. Supraventricular tachycardia. Mayo Clinic. Accessed November 27, 2024. https://www.mayoclinic.org/diseases-conditions/supraventricular-tachycardia/symptoms-causes/syc-20355243

3. Supraventricular tachycardia in adults. Patient. June 29, 2022. Accessed November 27, 2024. https://patient.info/doctor/supraventricular-tachycardia-in-adults

4. Paroxysmal Supraventricular Tachycardia. Medscape. April 5, 2017. Accessed November 27, 2024. https://emedicine.medscape.com/article/156670-overview#a6