Sanofi-aventis Stands Behind the Safety of Lantus(R)
BRIDGEWATER, N.J., June 26 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) has just been made aware of data associated with a retrospective follow-up of four patient registries. The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus(R) (insulin glargine [rDNA] injection) use and the occurrence of malignancies, as the authors of the study point out.
Clinical studies, which represent the gold standard of evidence, do not indicate an association between insulin glargine and cancer.
"Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, sanofi-aventis stands behind the safety of Lantus(R)," said Jean-Pierre Lehner, M.D., Chief Medical Officer. "We consider that the results of these patient registries are not conclusive."
Patient safety is the primary concern of sanofi-aventis. The Group will continue to vigorously monitor the safety of Lantus(R) in close collaboration with regulatory agencies and scientific experts.
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).
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