The US Food and Drug Administration has granted Amgen a priority review for ivabradine, licensed from Servier, for the treatment of chronic heart failure.

The latest designation comes some four months after the FDA granted fast track designation for ivabradine, which is already approved in Europe under the brand name Procoralan for stable angina and chronic heart failure. Amgen got US rights to sell the pill through a cross-licensing pact signed with Servier a year ago.

Ivabradine slows heart rate without negative effects and was filed on the back of data from a Phase III study, called SHIFT. That trial compared the drug to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate of less than 70 beats per minute.

Amgen R&D chief Sean Harper said that the priority review designation “is evidence that chronic heart failure is a serious condition, which leads to high rates of rehospitalisation 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," he added.

Getting priority review means that the FDA will take action on a New Drug Application within six months of it being received.