Biotech company Amgen Inc. took a key step in its expansion into cardiovascular drugs Wednesday when the Food and Drug Administration approved its heart failure drug for sale in the United States.
The drug called ivabradine is an oral medication that treats chronic heart failure by slowing the heart rate. Amgen will sell it under the brand name Corlanor.
Amgen obtained the U.S. commercial rights for ivabradine in 2013 from French company Les Laboratoires Servier, which developed the drug and sells it in Europe.
Heart failure is a condition in which the heart is weakened and unable to pump enough blood to the body.
To compensate for its weakened condition, the heart often speeds up — creating additional complications.
Ivabradine slows the heart rate by inhibiting current in the body's natural pacemaker. It has been proved to reduce the risk of hospitalization for people with worsening heart failure, Amgen said.
Heart failure affects more than 5 million people in the United States, and about 50% of people with the condition die within five years, according to the American Heart Assn.
Sean Harper, executive vice president of research and development at Amgen, said he believes about 1 million people in the United States would be suitable candidates for the new drug.
"That's a pretty significant number of patients," he said. "We believe the drug will be adopted quite rapidly."
He declined to predict how much revenue it could mean for the company. "I think it can have a meaningful impact," he said. "Time will tell."
Corlanor is the first new chronic heart failure medicine approved by the FDA in nearly a decade, Harper said.
"Many heart failure patients are repeatedly admitted to the hospital, which can cause a great burden on the patient and on healthcare resources," he said. "We hope that today's approval of Corlanor as an innovative therapeutic option will address a major unmet need for patients, their families and the healthcare system."
Corlanor is Amgen's first drug used to treat cardiovascular disease. Until this point, the company had focused on drugs that treat cancer, arthritis, osteoporosis, anemia and other conditions.
Founded in 1980, Amgen specializes in biologic drugs, injectable medicines made from living cells. Because Corlanor is an oral medication, it will be an unusual addition to Amgen's lineup.
"All things being equal, we tend to prefer to use biologics," Harper said. "But in this case, ivabradine has been around outside the U.S. for a long time and in clinical use around the world for a long time. So we're pretty confident about the characteristics."