Boston, MA 08/28/2014 (wallstreetpr) – The U.S. biotechnology company Amgen, Inc. (NASDAQ:AMGN) declared in its press report that it had received a green signal from the U.S. Food and Drug Administration (FDA) for the priority review designation for ‘ivabradine.’
The effectiveness of the oral drug Ivabradine:
Ivabradine is an oral drug used for the treatment of chronic heart failure (HF). The oral medicine slows down the current in the sinoatrial node, the cardiac pacemaker of the body. In fact, the drug reduces the heart rate and creates no adverse effect on the myocardial contractility or ventricular repolarization.
The executive vice president of Amgen says:
Almost 26 million people are affected by cardiac failure across the globe. Among them, the number of people affected in the U.S. is approximately 5.1 million. Amgen, Inc. (NASDAQ:AMGN)’s executive vice president of Research and Development, Sean E. Harper, M.D, stated that the grant of the priority review designation by FDA indicates that chronic heart failure is a very severe problem.
It leads to high rates of rehospitalization and poor prognosis while there are treatments available for the same. Sean also said that if ‘ivabradine ‘ is approved, it can prove to be highly significant for the treatment of chronic heart failure. The Amgen, Inc. (NASDAQ:AMGN) is very optimistic to bring the treatment valid for the U.S. patients suffering from chronic heart failure.
The Phase III SHIFT studies:
The new drug application is based on the global clinical trial data of Phase III SHIFT study. The SHIFT study result achieved from more than 6500 patients in sinus rhythm is capable of reducing left ventricular function and heart rate >70 beats per minute (BPM). The Priority review designation for ivabradine, which treats the serious cardiac conditions, if approved, can offer much better safety on the diagnosis, treatment as well as anticipation of severe conditions compared to other therapies.
