Sanofi-Aventis got another backer in its bid to defend Lantus from safety charges. European regulators backed the diabetes drug, saying that recent studies questioning its safety were flawed. But the agency requested that Sanofi conduct further research into Lantus and cancer.
The European Medicines Agency had launched a safety review after studies in Diabetologica suggested a link between the diabetes treatment and increased risk of cancer and death from cancer. "Due to methodological limitations the studies were found to be inconclusive," the EMEA said in a statement. "[C]hanges to the prescribing advice are therefore not necessary."
Sanofi, of course, welcomed the news. "This is important and reassuring information for patients receiving Lantus," CMO Jean-Pierre Lehner said in a press release. "The 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."
Like FDA, the EMEA also directed Sanofi to study Lantus safety further. And the Committee for Human Medicinal Products is casting about for ways to cooperate with academia to generate more data, it said. Stay tuned.
- see the Sanofi release
- read the statement from EMEA
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