Sanofi moves to quell Lantus safety concerns
pharmafile | July 7, 2009 | News story | Research and Development, Sales and Marketing | Lantis, Sanofi-Aventis, diabetes
Sanofi-Aventis has rejected claims of a possible connection between its diabetes treatment Lantus and cancer.
The possible link was reported in the Journal of the European Association for the Study of Diabetes (EASD) – Diabetologia, which called for it to be looked into urgently.
But Sanofi-Aventis' chief medical officer Jean-Pierre Lehner said the company stands behind the safety of Lantus, adding: "We consider that the results of these patient registries are not conclusive."
The FDA is currently reviewing safety data to better understand the risk, if any, of cancer associated with the drug and the US regulator's European counterpart the EMEA is also set to investigate the claims.
However, the EMEA has so far noted that the results of the four studies were inconsistent, and that a relationship between the drug and cancer could neither be confirmed nor excluded.
The agency stressed patients being treated with Lantus should continue their treatment as normal.
Sanofi has said it will collaborate with regulators and continue to monitor the drug's safety.
Claims
Lantus is Sanofi-Aventis' third biggest medicine and generated $3.5 billion last year.
Diabetologia said observational studies had found a statistically significant link between patients who had used Lantus and those who had been diagnosed with cancer.
Professor Edwin Gale, editor of Diabetologica, and Professor Ulf Smith, president of EASD, said: "We believe people are entitled to know that use of Lantus insulin might be associated with greater risk but this must also be balanced against the possibility that we may be causing unnecessary alarm by raising these concerns."
But Gale and Smith acknowledged there were limitations to the studies.
The main limitation is that the characteristics of patients taking Lantus (insulin glargine, an insulin analogue) are generally different to those on other forms of insulin.
"Therefore any difference in cancer risk could be attributed to the pre-treatment characteristics of the groups, rather than the treatment itself," they said.
Chris Viehbacher, chief executive of Sanofi-Aventis, warned against jumping to conclusions and said: "All of what we know supports the safety of Lantus."
The company emphasised the fact that Diabetologica itself states no definitive conclusions can be drawn regarding a relationship between Lantus and cancer and welcomed further studies.
The FDA and EMEA will now review Lantus' safety data, addressing among other things the influence of patient characteristics on the risk of cancers.
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