On Wednesday, April 15, the Food and Drug Administration approved Amgen's new heart failure drug called ivabradine (Corlanor), Forbes reported.
The drug, which has been available for many years in Europe, is expected to control heart rate and decrease the risk of hospitalization for worsening heart failure in people with chronic heart failure. Amgen said that the list price for the drug Corlanor will be $375 each month, without insurance.
More than five million people in America suffer from heart failure, a medical condition in which the heart is not able to pump out sufficient oxygen-rich blood. Heart failure can result from a heart attack or other causes. It is a major cause of hospitalizations.
The agency approved the drug based on results of the SHIFT trial that was published in 2010. The trial studied 6,558 people with heart failure who had a heart rate above 70 beats per minute. After 22 months of followup, the rate of hospital admission for worsening heart failure or cardiovascular death was 29 percent in the placebo group and 24 percent in the ivabradine group.
According to the FDA, some of the common side effects of the drug were temporary vision disturbance (flashes of light), atrial fibrillation, high blood pressure or hypertension and bradycardia. The FDA cautioned that women should not conceive while taking ivabradine because it can hurt fetuses.
In the meantime, the Food and Drug Administration is reviewing another heart failure pill, from Novartis AG, and could approve it soon, according to ABC News. Novartis has not set the price of its drug yet.