Procoralan® Receives European Approval for Use in Heart Failure

Paris.(PRNewswir) Approval brings promise of better prognosis and improved quality of life for millions of chronic heart failure patients in EuropeServier today announced that the company’s heart rate lowering agent, Procoralan® (ivabradine), the first selective If channel inhibitor, has been approved by the European Commission for the treatment of patients with chronic heart failure. The European Commission’s decision to authorise this new indication for Procoralan followed the review of data from the SHIfT trial, the largest-ever morbi-mortality study of treatments for chronic heart failure involving more than 6000 patients. It demonstrated that the treatment significantly reduced the risk of death and hospitalisation from heart failure, and improved the quality of life of people living with the disease.[2,3] This reduction in mortality was highly significant in patients with a heart rate of 75 beats per minute (bpm), or above, for whom Procoralan is now indicated.Professor Michel Komajda, Co-Chairman of the SHIFT Executive Committee commented: “The decision to authorise this new indication for Procoralan is good news for doctors and patients, and is a significant step forward in the treatment of heart failure. While ACE inhibitors and beta-blockers remain the main stay in the treatment of heart failure, the results of the SHIfT trial demonstrate that a reduction in heart rate when elevated with Procoralan improves clinical outcomes and symptoms, prevents disease progression, and has beneficial effect on daily activities and the quality of life of heart failure patients”.
Chronic heart failure affects 15 million patients in Europe (2% to 3% of the overall population).[4] It is a disabling condition and, despite improvements in treatment and management, generally has a poor prognosis. Heart failure impairs the heart’s ability to pump effectively and to maintain sufficient circulation to meet the body’s needs.