FDA Approves Corlanor for Chronic Heart Failure
Works by decreasing heart rate; first approved product in this drug class
THURSDAY, April 16, 2015 (HealthDay News) -- Corlanor (ivabradine) has been approved by the U.S. Food and Drug Administration to treat chronic heart failure, the agency said in a news release.
It is recommended that people who take Corlanor have a stable resting heartbeat of at least 70 beats per minute and take beta-blocker medication at the highest tolerable dose, the FDA said.
The drug was evaluated in a clinical trial of 6,505 people. The most common side effects included bradycardia, hypertension, atrial fibrillation, and temporary vision disturbance (flashes of light). Users should contact a doctor without delay if they have symptoms such as irregular heartbeat, a feeling that the heart is racing or pounding, have chest pressure, or worsening shortness of breath. Women who are pregnant or expect to become pregnant should avoid the drug, the FDA said.
"Heart failure is a leading cause of death and disability in adults," Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class."
Corlanor is manufactured by Amgen, based in Thousand Oaks, Calif.