The Food and Drug Administration (FDA) has approved the use of Corlanor (ivabradine; Amgen) for the treatment of stable symptomatic heart failure (HF) due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.
The approval was based on a randomized, double-blind, placebo-controlled trial in 116 patients aged 6 months to less than 18 years with symptomatic DCM in sinus rhythm, NYHA/Ross class II to IV HF, and left ventricular ejection fraction ≤45%. The primary endpoint of the study was ≥20% reduction in resting heart rate from baseline without bradycardia or symptoms after an initial titration period.
Results showed a higher proportion of patients achieved target heart rate reduction with Corlanor compared with placebo (72% vs. 16%, respectively; odds ratio = 15; 95% CI 5, 47). Moreover, a statistically significant reduction in heart rate was observed with Corlanor compared with placebo at the end of the titration period (-23 ± 11 vs -2 ± 12 beats per minute [bpm], respectively).
In addition to the new indication, an oral solution formulation of Corlanor has also been approved. Each 5mL ampule contains 5mg of ivabradine and is packaged in cartons containing 28 foil pouches; the oral solution is expected to be available in late July. Corlanor is also available in 5mg and 7.5mg tablets.
Corlanor, a hyperpolarization-activated cyclic nucleotide-gated channel blocker, is also approved to reduce the risk of hospitalization for worsening HF in adult patients with stable, symptomatic chronic HF with left ventricular ejection fraction ≤35%, who are in sinus rhythm with a resting heart rate ≥70 bpm and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.
For more information visit corlanor.com.