Lantus insulin glargine regulatory update

EMA's CHMP concluded that new data from 3 population-based studies do not show an increased risk of cancer associated with insulin glargine-containing medicines, including Sanofi's diabetes drug Lantus insulin glargine, and the drugs' benefit/risk profiles remain unchanged. The committee also noted that there is no known mechanism by which insulin glargine would cause cancer and that a cancer risk has not been seen in laboratory studies. The studies included 2 cohort studies - 1 study in about 175,000 patients in northern Europe and the other in about 140,000 patients in the U.S. - which evaluated the occurrence of breast, colorectal and prostate cancer with the various insulins, as well as a case-control study conducted in Canada, France and the U.K., which compared 775 diabetics who had breast cancer vs. a control group of diabetics who did not have breast cancer.

The committee reviewed the products after 4 registry studies published in 2009 raised concerns of a possible link between insulin glargine and cancer. In July 2009, CHMP concluded a link between insulin glargine and cancer could not be confirmed or excluded from the results following an "in-depth" review. CHMP said it requested further data, and Sanofi conducted further studies and submitted the results to the committee for review. ...