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14 February 2012

Procoralan® Receives European Approval for Use in Heart Failure

Servier today announced that the company's heart rate lowering agent, Black Triangle DrugProcoralan(R) (ivabradine), the first selective If channel inhibitor, has been approved by the European Commission for the treatment of patients with chronic heart failure.
"Heart failure patients with elevated heart rates are at a significantly greater risk of death or hospitalisation, and the poor quality of life experienced by these patients is associated with worse disease outcomes. The results of the SHIfT morbi-mortality clinical study demonstrated that Procoralan has the potential to not only improve clinical outcomes for patients with chronic heart failure but in addition could also improve physical and emotional wellbeing. We are convinced that Procoralan will become a valuable new option for healthcare professionals in the treatment of heart failure" said Dr. Emmanuel Canet, Head of Research and Development for Servier.
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. 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".

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