Amgen’s Corlanor (ivabradine) Receives FDA’s Approval to Reduce Risk of Hospitalization for Worsening Heart Failure in Patients with Chronic Heart Failure

Shots:

• The approval is based on P-III SHIFT study trial assessing Corlanor vs PBO +SoC in 6500+ patients with reduced left ventricular function (LVEF ≤35%) and heart rate ≥70 bpm, hospitalization for heart failure within the past 12 months
• The P-III study resulted in reduction in risk of primary composite endpoint of hospitalization or cardiovascular death for worsening heart failure, 18% relative risk reduction (RRR) and 4.2% absolute risk reduction (ARR), no effect on motality, 2.6% RRR (4.7% ARR)
• Corlanor (ivabradine) is an oral drug with recommended dose 5mg (bid) that blocks hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker, which regulates heart rate

Click here to read full press release/ article | Ref: Amgen | Image: Signbox