EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine.
Corlentor/Procoralan was developed by independent French drugmaker Servier and is approved to treat symptoms of angina and to treat heart failure. Last year, commercial rights to the drug were licensed to US biotech firm Amgen (Nasdaq: AMGN for the US market (The Pharma Letter July 10, 2013).
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