FDA
FDA expands Rapiblyk indication to pediatric supraventricular tachycardia
FDA has approved Rapiblyk (landiolol) for the short-term reduction of ventricular rate in pediatric patients from birth to <18 years with supraventricular tachycardia (SVT), expanding its indication beyond adults in critical care settings. Rapiblyk is an ultra–short‑acting, selective beta‑1 adrenergic receptor blocker administered intravenously in monitored hospital environments. Previously, the drug was approved for use in adults with SVT, including atrial fibrillation and atrial flutter, particularly in perioperative and critical‑care contexts.
“With this expanded indication, Rapiblyk becomes available as a treatment option for pediatric patients with SVT in the US,” said John Kimmet, General Manager of AOP Health US in a news release.
Efficacy
Approval for the pediatric population is based on the phase 3 LANDI‑PED study, a prospective, open‑label trial that enrolled 60 children aged 1 day to 18 years with SVT in surgical and nonsurgical settings. Patients received a continuous IV infusion of landiolol titrated up to 40 mcg/kg/min for as long as 24 hours. The primary endpoint was restoration of normal sinus rhythm within 210 minutes of infusion start; 25% of patients achieved conversion within that timeframe. In addition, 40% experienced at least a 20% reduction in heart rate by 210 minutes (rising to 51.7% by the end of infusion), demonstrating clinically meaningful rate control in this population.
Safety
Safety in pediatric patients was consistent with the known beta‑blocker profile. In LANDI‑PED, the most common adverse reaction was hypotension (≈10%). The prescribing information includes warnings and precautions regarding hypotension, bradycardia, and cardiac failure, potential exacerbation of reactive airway disease, masking of hypoglycemia in patients with diabetes, and the need for careful monitoring when discontinuing therapy—particularly in those with coronary artery disease. Rapiblyk is contraindicated in conditions such as severe sinus bradycardia, advanced heart block, decompensated heart failure, cardiogenic shock, pulmonary hypertension, or hypersensitivity to landiolol.