French drug maker Sanofi (SNY: Quote) on Wednesday announced that a new meta-analysis on the relationship between diabetes and cancer risk demonstrates no increased risk in people using its insulin Lantus (insulin glargine). The company presented the new meta-analysis data reinforcing safety profile of Lantus at the World Diabetes Congress in Dubai.
Lantus is the world's top- selling insulin with $4.7 billion in annual revenue.
Earlier, a study presented at the San Antonio Breast Cancer Symposium reportedly showed that Lantus more than doubled the risk of developing cancer among people with diabetes. The researchers, who examined medical records of 23,266 patients in southern Sweden, were unable to identify the types of most common cancer among Lantus users.
Sanofi noted that the analysis of all its published studies, from more than 80,000 patients enrolled in clinical trials and 38 million patient years of treatment exposure to Lantus, further expand the evidence base on the safety.
Peter Boyle, the study Principal Investigator and President of the International Prevention Research Institute (IPRI), Lyon, France, said, "In the context of all available information, the current evidence supports that insulin glargine is associated with no increased risk of cancer as compared to other insulin therapies. These findings are reassuring for patients and their physicians."
Sanofi pointed out that the meta-analysis on observational studies derived from databases as well as from randomized controlled clinical trials. Also, a case-control study in numerous countries, such as Sweden, Germany, Scotland, England and Taiwan, assessed the risk for cancer in individuals with diabetes using different insulins.
Sanofi further said that independent investigators are currently conducting three large studies, sponsored by the company, to find out any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. These include two retrospective cohort studies and one case-control study.
Final results of the first study based on Nordic databases will be communicated to regulatory agencies by the end of 2011 and scientific presentations are expected to follow in 2012.
In Paris, Sanofi shares closed Wednesday's trading at 52.84 euros, up 1.03 euros or 1.99 percent. SNY closed at $35.60, up $0.60 or 1.71 percent.
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by RTT Staff Writer
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