Procoralan ivabradine regulatory update
EMA’s CHMP recommended measures to reduce the risk of heart problems, such as heart attack and bradycardia, in patients receiving Corlentor/Procoralan ivabradine to treat angina and heart failure (HF). CHMP recommends that ivabradine only be started if the patient’s resting heart rate is =70 bpm and be used to treat symptoms of angina. CHMP also advised doctors against prescribing ivabradine with medicines that reduce heart rate and recommended monitoring for atrial fibrillation (AF). The recommendations follow a review of data from the double-blind, international Phase III SIGNIFY trial, which showed a significant increase in the risk of cardiovascular death vs. placebo and a higher risk of bradycardia vs. placebo (see BioCentury, Sept. 8). ...