Based on existing evidence CHMP (the EMEAâ€™s Committee for Medicinal Products for Human Use) concludes that no changes to the prescribing advice are necessary
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that following the review of the available evidence on LantusÂ® (insulin glargine [rDNA] injection), the European Medicines Agencyâ€™s Committee for Medicinal Products for Human Use (CHMP) confirmed the productâ€™s safety and concluded that changes to the prescribing advice are not necessary.
The EMEA issued a press-release stating that they have re-confirmed their initial assessment, based on an in-depth review of existing evidence and of the recent publications of registry analyses in Diabetologia. All four registry analyses were found to have significant methodological limitations and to provide inconsistent and inconclusive results regarding a potential link between LantusÂ® use and an increased risk of cancer.
â€œThis is important and reassuring information for patients receiving LantusÂ®. The clinical usage of LantusÂ®Â should continue unchangedâ€, said Dr. Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. â€œThe review conducted by the CHMP included the analyses of the articles recently published in Diabetologia and confirmed that they do not justify new clinical recommendations to patients.â€
Sanofi-aventis will implement a set of actions to develop further research in this area. These actions are in line with recommendations recently made by an independent team of interdisciplinary medical experts on this subject.
Patient safety is and has always been the primary concern of sanofi-aventis. Sanofi-aventis has
80 years of experience in the development of insulins and stands behind the safety of LantusÂ®. Extensive data involving over 70,000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence, and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between insulin glargine and cancer.
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, approximately 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c <7 percent recommended by the ADA. The HbA1c test measures average blood glucose levels over the past two- to three-month period.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
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