Procoralan ivabradine regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that patients taking Corlentor/Procoralan ivabradine should be monitored because they are at an increased risk of developing atrial fibrillation (AF). The PRAC also recommended that Procoralan be used to treat angina only to alleviate symptoms, noting that the available data do not indicate that the drug provides benefits on outcomes such as reducing heart attack or cardiovascular death. Servier markets Procoralan in at least 100 countries to treat stable angina and chronic heart failure (CHF). ...