FDA approves Amgen heart drug
The U.S. Food & Drug Administration today approved Amgen’s drug Corlanor, a heart failure treatment.
The drug, aimed at reducing hospitalization for patients whose condition is long-lasting, is the first chronic heart failure medication approved by the FDA in nearly a decade. It was approved under the FDA’s priority review program, an expedited process for drugs that could introduce an improvement in existing treatment for serious conditions.
An estimated 5.1 million Americans suffer from chronic heart failure, and the condition costs the U.S. about $31 billion annually in costs related to hospitalization.
Heart failure is a leading cause of death and disability in adults,” Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.”
Earlier this month, European regulators approved Amgen’s colorectal cancer drug Vectibix as a first-line treatment used in combination with chemotherapy.