Sanofi-Aventis Provides Expert Report On Lantus

Sanofi-Aventis has released a report by a multidisciplinary board of renowned international experts, following an in-depth assessment of the recent publications of registry analyses with Lantus in Diabetologia.

The specialists concluded that all four manuscripts have significant methodological limitations and shortcomings, providing inconsistent and inconclusive results regarding a potential link between insulin glargine use and an increased risk of cancer.

The statement was signed by 14 international experts following their independent and thorough review of the published data.

The experts proposed a set of actions to be implemented by the company and by independent experts or professional associations, that they believe will lead to a clear and definite conclusion on this situation.

Jean-Pierre Lehner, chief medical officer of Sanofi-Aventis, said: “This position from leading world experts is consistent with previous assessments of the published analyses. What we know about the safety of Lantus comes from a robust clinical program that includes prospective, randomized clinical trials, supported by solid post-marketing surveillance observations. We are moving forward confidently with the external scientific and medical experts and health authorities toward next steps to resolve this controversy.”