Amgen Gets FDA Priority Review For Heart Drug - Update

(RTTNews) - Amgen Inc (AMGN) said Wednesday the U.S. Food and Drug Administration has granted a priority review status for its new drug application of ivabradine, an investigational drug for chronic heart failure.

Ivabradine is an oral drug that inhibits the "funny" current in the sinoatrial node, the body's cardiac pacemaker. The drug works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.

Priority review status is assigned to applications for drugs that treat serious conditions and would, if approved, be effective when compared with available therapies. The assignment of priority review status means the FDA will act on the application within six months.

In April, the FDA granted fast track designation for ivabradine.

"The priority review designation by the FDA is evidence that chronic heart failure is a serious condition.... ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies," said Sean Harper, executive vice president of Research and Development at Amgen.

The new drug application for ivabradine is based on data from a Phase 3 trial that compared the drug to placebo on top of standard-of-care therapies.

Developed by Les Laboratoires Servier, ivabradine was approved by the European Medicines Agency as procoralan in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure in patients with elevated heart rates. Amgen, through a collaboration with Servier, has rights to commercialize ivabradine in the U.S.

Heart failure is a common condition that affects about 26 million worldwide, including nearly 5.1 million people in the U.S.

Amgen is trading at $137.71, up $0.44 or 0.32%, on a volume of 1.3 million shares on the Nasdaq.