Rapiblyk FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 30, 2024.
FDA Approved: Yes (First approved November 22, 2024)
Brand name: Rapiblyk
Generic name: landiolol
Dosage form: Lyophilized Powder for Injection
Company: AOP Orphan Pharmaceuticals GmbH
Treatment for: Supraventricular Tachycardia
Rapiblyk (landiolol) is an ultra-short acting cardioselective beta-1 adrenergic blocker for for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
- Supraventricular tachycardia is a heart condition characterised by an irregularly fast or erratic heartbeat.
- Beta-1 adrenergic blockers are used frequently in critical care settings to manage supraventricular tachycardia, but can have the unwanted effects of decreasing the contractility of the heart, and of lowering blood pressure. As a cardioselective beta-1 adrenergic blocker, landiolol works to reduce heart rate with minimal effect over cardiac contractility (inotropy) and minimal impact on blood pressure.
- FDA approval of Rapiblyk was based on data from five randomized, double-blind, placebo-controlled studies which demonstrated a heart rate decrease in 40% to 90% of patients treated with Rapiblyk within about 10 minutes, compared to 0% to 11% of patients receiving placebo.
- Rapiblyk is administered by intravenous infusion in a monitored setting.
- Warnings and precautions associated with Rapiblyk include a risk of hypotension, bradycardia, and cardiac failure; risk of exacerbating reactive airway disease; prevention of early warning signs of hypoglycemia and increased risk for severe or prolonged hypoglycemia in patients with diabetes mellitus; and myocardial ischemia in patients with coronary artery disease.
- The most common adverse reaction (9.9%) is hypotension.
Development timeline for Rapiblyk
Further information
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