Amgen Statement on EMA Review of Ivabradine

Developed by Servier, ivabradine was approved by the European Medicines Agency (EMA) as PROCORALAN^® in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure in patients with elevated heart rates. Ivabradine is an oral drug that inhibits the I_f current ('funny' current) in the sinoatrial node, the body's cardiac pacemaker.¹

Through a collaboration with Servier, Amgen has rights to commercialize ivabradine in the U.S.

In April 2014, Amgen announced that the U.S. Food and Drug Administration (FDA) granted fast track designation for investigational ivabradine for patients with chronic heart failure. Amgen plans to submit the FDA filing for ivabradine for patients with chronic heart failure, which is planned for Q2 2014.

In May 2014, the EMA started a review of ivabradine following preliminary results from Servier's SIGNIFY (Study assessInG the morbidity-mortality beNefits of the I_f inhibitor ivabradine in patients with coronarY artery disease) study. The SIGNIFY study is a randomized, double-blind, parallel-group, placebo-controlled, event-driven study (n=19,102) conducted in 51 countries by Servier to evaluate the role of heart rate lowering with ivabradine in patients with chronic stable coronary artery disease without heart failure.

In the SIGNIFY study, patients received, on top of their usual treatment, up to 10 mg ivabradine twice daily, which is higher than the currently authorized maximum daily dose in the EU (7.5 mg twice daily). Preliminary results of the SIGNIFY study showed a small but significant increase in the combined risk of cardiovascular death and myocardial infarction with ivabradine in a subgroup of patients with chronic stable angina without heart failure.

Amgen continues to expect to submit the FDA filing for ivabradine for patients with chronic heart failure in Q2 2014.

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