The Food and Drug Administration (FDA) announced the approval of Corlanor (ivabradine; Amgen) to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35%, who are in sinus rhythm with resting heart rate ≥70bpm, and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.

Corlanor works by blocking the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker. It reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current to slow the heart rate with no effect on ventricular repolarization and no effects on myocardial contractility.

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The approval of Corlanor was based on the Phase 3 SHIFT study (n=6,505) that compared Corlanor to placebo in addition to standard of care. Results showed that Corlanor significantly reduced the risk of the primary composite endpoint of hospitalization or cardiovascular death for worsening heart failure with a 18% relative risk reduction (4.2% absolute risk reduction; P<0.0001) vs. placebo. There was a 26% relative risk reduction (4.7% absolute risk reduction) in the risk of hospitalizations for worsening heart failure.

Corlanor was reviewed through the FDA’s priority review program and was granted fast track designation. It will be available as 5mg and 7.5mg tablets in 60- and 180-count bottles in approximately one week.

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