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Medicines licensing

FDA fast tracks ivabradine’s heart failure licence, years after Europe

The US Food and Drug Administration (FDA) has granted a licence for the heart failure medication ivabradine, ten years after the drug was first approved in Europe.

Ivabradine is now licensed in the United States to reduce hospital admissions from worsening heart failure.

The European Medicines Agency (EMA) approved ivabradine in 2005 to treat the symptoms of angina and in 2012 the drug was granted a licence for use in heart failure. Ivabradine is thought to work by slowing the heart rate. Amgen, the manufacturer of ivabradine, submitted its application for FDA approval of the medicine in June 2014. The US medicines regulator put the medicine in its priority-review programme after having designated it for fast-track approval.

However, the medicine was the subject of safety concerns in 2014 after a study suggested that ivabradine increases the risk of heart attack, slow heart rate and atrial fibrillation in a subgroup of patients with symptomatic angina. In the UK, healthcare professionals were warned that the medicine should only be used in patients with a heart rate of at least 70 beats per minute, that it should not be combined with other drugs that slow the heart rate and that if atrial fibrillation occurs then stopping the medicine should be considered.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068360

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