FDA approves first heart drug in almost a decade

There's new hope for patients in the fight against chronic heart failure.

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Amgen

On Wednesday, the U.S. Food and Drug Administration approved Amgen's Corlanor, a drug that helps reduce the risk of hospitalization for patients with systolic heart failure, which develops when the heart's left ventricle becomes weaker and cannot pump enough blood. The medication, generically known as ivabradine, is the first new heart drug the agency has approved in almost 10 years.

"It's an oral pill that's taken twice a day, and basically what it does is target the heart rate," said Dr. Tara Narula, cardiologist at Lenox Hill Hospital in New York. "We know patients with heart failure don't do well when their heart rates climb. And so this drug specifically targets the pacemaker cells in the heart, the ones that produce the heartbeat, to slow them down as much as 15 points."

Existing, standard drugs used for heart failure not only slow the heart rate, but also drop the patients' blood pressure, Narula said. Corlanor, however, does not lower blood pressure, so it is meant to "essentially be added to the regimen, not to replace it."

Narula said she would "absolutely" prescribe this drug to her patients.

Dr. Narula noted that "this is a really big deal. Studies have shown this drug can decrease the risk of hospitalization and cardiovascular death" by 18 percent, driven by a reduction in the risk of hospitalization due to worsening heart failure.

Corlanor doesn't come cheap, however, with a cost of about $375 a month. And the FDA has warned about the drug's possible side effects.

"They're low, but the biggest one is bradycardia, which is the slowing of the heart rate, a small risk of atrial fibrillation, or irregular heart rate, some vision changes and some increased blood pressure," Narula said.

According to the FDA, heart failure affects about 5 million people in the U.S. It is a leading cause of disability and death, and there is no cure.

Narula said part of the reason it took almost 10 years to get a new heart drug on the market is because heart failure is a complicated disorder that activates a lot of different systems in the body. She said there is another new drug in the pipeline from Novartis called LCZ696 that has also been shown to decrease the risk of re-hospitalization; it could be approved by the FDA this summer.