Novel Heart Failure Drug Wins FDA Approval
Amgen plans to launch its Corlanor heart failure drug immediately, following FDA approval last week.
The agency approved Corlanor (ivabradine) on top of beta blockers, the current standard of care, for patients with stable symptoms of chronic heart failure and a normal heartbeat with a resting rate of at least 70 beats per minute who are taking the highest tolerable dose of beta blockers.
The goal, the FDA says, is to prolong the time to hospitalization in patients whose hearts beat at least 70 times per minute in normal rhythm, but at less than 35 percent of normal capacity, and who are either on the maximum dose of beta blockers or are unable to tolerate them.
Not only is Corlanor (ivabradine) the first new heart failure drug approved in nearly a decade, but it’s also the first of its drug class, Amgen says. The drug is thought to work by decreasing resting heart rates, thus putting less stress on an already taxed organ.
In a Phase III trial of more than 6,500 patients, Corlanor reduced the risk of hospitalization by 18 percent compared to the current standards of care, according to the company. This not only reduces stress on patients whose hearts are vulnerable, but also will save the U.S. healthcare system billions of dollars, Amgen says.
Between 5 million and 6 million people in the U.S. live with heart failure, costing the healthcare system about $31 billion per year, mostly due to in-patient care. — Lena Freund