FDA priority review for Amgen’s ivabradine in CHF

The US Food and Drug Administration has granted priority review designation for US biotech giant Amgen’s (Nasdaq: AMGN) ivabradine for the treatment of chronic heart failure (HF), with the news causing the firm’s share to hit a 52-week high of $137.99.

Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker. Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular re-polarization. Heart failure is a common condition that affects around 26 million worldwide, including about 5.1 million people in the USA.

"The priority review designation by the FDA is evidence that chronic heart failure is a serious condition, which leads to high rates of re-hospitalization and poor prognosis despite available treatments. If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition," said Sean Harper, executive vice president of R&D at Amgen.