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Review of ivabradine (Procoralan/Corlentor) benefit/risk ratio08/05/2014
(Suresnes), May 8th 2014– SERVIER announces that the European Medicines Agency has started a review of the benefit/risk ratio of ivabradine (Procoralan/Corlentor).
This review follows preliminary results from the SIGNIFY study. This study was carried out by Servier in order to evaluate the efficacy of Procoralan/Corlentor in preventing cardiovascular events (cardiovascular death and myocardial infarction) in patients with coronary heart disease without heart failure. In this study patients received on top of their usual treatment up to 10mg Procoralan/Corlentor twice daily, which is higher than the currently authorized maximum daily dose (7.5 mg twice daily). The results showed a small increase in the combined risk of cardiovascular death and myocardial infarction with Procoralan/Corlentor in a subgroup of patients with chronic stable angina without heart failure.
Procoralan is currently authorized and used in the treatment of chronic stable angina (chest pain due to obstruction in the arteries in the heart) or in heart failure (when the heart cannot pump enough blood to the rest of the body). At this stage the conditions of use of Corlentor/Procoralan remain unchanged and Servier underlines the importance of strictly following the conditions of use in the Summary of Product Characteristics.
Patients can ask their usual doctor or pharmacist if they have any questions.
SERVIER has already informed all the concerned Regulatory Authorities about this data and will provide health care professionals with detailed information indicating the practical consequences for patients as soon as it is made available by the European Medicines Agency.
Ivabradine lowers heart rate. In coronary patients, ivabradine reduces or prevents angina symptoms. In heart failure patients, ivabradine slows the progression of the illness.
Ivabradine obtained a European marketing authorization on 25th October 2005. It is available in 102 countries.
About the review by the European Medicines Agency (EMA)
The review was started at the request of the European Commission according to article 20 in the EC code No 726/2004. It will be carried out by the PRAC (Pharmacovigilance Risk Assessment Committee), the committee responsible for evaluating safety concerns about medicines for human use. The PRAC will make its recommendations to the CHMP (Committee for Medicinal Products for Human Use) in the EMA, which will adopt a final position.
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