Amgen’s Heart Failure Drug Gets Approval From FDA

The U.S. Food and Drug Administration has announced on Wednesday the approval of a new drug used to treat heart failure. After almost a decade, ivabradine finally gets the agency’s approval.

Ivabradine (Corlanor), made by California-based pharmaceutical company Amgen, received its FDA approval for the treatment of heart failure. In a report by Larry Hussen from Forbes, the drug is indicated for use in patients with stable heart failure with sinus rhythm, a resting heart rate not less than 70 bpm and for those who are also taking a high dose of beta blocking agents.

Current drugs available in the market that are used as standard treatment for heart failure also lower the blood pressure in addition to slowing the heart rate. On the other hand, Corlanor doesn’t reduce the blood pressure so it is not meant to be a replacement, but instead an addition to an existing regimen, according to Dr Tara Narula, a 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,” said Narula.

Meanwhile, State University of New York, Downstate Medical Center chief of cardiovascular medicine, Jeffrey S. Borer believes that the drug approval is “an important step forward for the treatment of patients with chronic heart failure in the U.S.”, due to its unique mechanism of action that supplements the standard heart failure treatments.

The decision to approve the drug was based on the safety and efficacy trials performed in 6,505 participants. As stated in the news release found on the official FDA website, the drug’s common side effects include hypertension, bradycardia and temporary vision disturbances. Ivabradine is also prohibited during pregnancy as it causes harm to the foetus.

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