The FDA has determined that Sanofi-Aventis’ blockbuster diabetes drug Lantus cannot be linked conclusively with an increased risk of cancer. The drug, a long-acting, modified version of human insulin, has been under review by the agency for more than a year after a series of observational studies suggested that an increased cancer risk might be present. But the FDA said this month it could not verify the results of those studies. “FDA has reviewed the four studies and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis,” the agency says.
Washington Drug Letter