FDA approves new type of heart failure drug from drugmaker Amgen
Patients with chronic heart failure, a disabling, deadly disease that worsens as the heart gradually pumps less efficiently, are getting a much-needed new option with U.S. approval Wednesday of a novel drug from Amgen Inc.
Corlanor is the first medication in a dozen years for heart failure, which is becoming more common with obesity — and more people surviving heart attacks due to better treatments.
Meanwhile, the Food and Drug Administration is reviewing another heart failure pill, from Novartis AG, and could approve it this summer.
More than 5 million Americans and more than 25 million people worldwide have heart failure, which kills up to half of patients within five years, despite numerous generic pills and other treatments available. It costs the global economy an estimated US$108 billion annually, mostly for repeated hospitalizations, so preventing those is a key cost-control target.
For most patients, it’s a chronic condition, caused by high blood pressure or other factors damaging heart muscle. That leaves many patients with “low-ejection fraction,” meaning the heart’s main pumping chamber can’t push out anywhere near the 50 percent or more of blood a healthy heart ejects.
Symptoms include breathlessness, fatigue and fluid retention. That keeps many patients homebound and causes repeated emergency department visits, often in the middle of the night, due to infections or just straying from a low-salt diet.
In patient tests the drugmakers funded, the new pills from Amgen, of Thousand Oaks, California, and Switzerland’s Novartis, the world’s biggest drugmaker by revenue, each made patients feel better and significantly reduced hospitalizations and deaths from heart failure.
“Both drugs benefited patients with ejection fraction less than 35 percent,” said Dr. Mary Norine Walsh, an American College of Cardiology vice president who oversees heart failure treatment and cardiac transplantation at St. Vincent Heart Center in Indianapolis.
She said doctors and patients await the new medicines, which work differently and target slightly different patient subgroups, with some overlap.
“The No. 1 thing is going to be how expensive” the drugs are and whether insurers set high co-pays — if they even cover them, Walsh stressed. “When we say to a patient that we’ll replace your medi- cine that you can get for US$4 (as a generic), nonmedical decisionmaking will come into play.”
Amgen says Corlanor’s list price will be US$375 per month, without insurance. Novartis hasn’t set its drug’s price yet.
After Corlanor’s approval was announced late Wednesday, its shares rose US$2.94, or 1.8 percent, to US$168.41 in after-hours trading. They rose US$2.90 in regular trading.
The FDA, which gave Corlanor priority review because of the need for better heart failure treatments, noted that women taking it shouldn’t become pregnant because of risk of harm to a fetus.