Sanofi-Aventis has received a further boost in its defence of Lantus after regulators in Europe played down claims in recent studies that suggested a link between the firm’s diabetes drug and and the risk of cancer.
The debate over Lantus (insulin glargine) began last month after three of four studies, published in the journal Diabetologia suggested an increased risk for cancer, especially breast cancer associated with use of the drug. Sanofi disagreed with those findings and last week issued a statement prepared by “a multidisciplinary board of renowned international experts” who said the findings were “inconclusive and inconsistent”.
That view has now been backed by the European Medicines Agency which says that the “available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary”. The agency, which carried out an “in-depth review”, goes on to say that “due to methodological limitations, the studies were found to be inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded”.
The EMEA concludes that its Committee for Medicinal Products for Human Use has noted that “the results of the studies were not consistent,” but it has called on Sanofi to “develop a strategy for generation of further research in this area”.
The European regulator’s stance mirrors that taken by the US Food and Drug Administration at the beginning of the month. The agency noted that the duration of patient follow-up in all four studies “was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure”.
Further support for Sanofi and Lantus came earlier this week in a Lancet online comment by statistician Stuart Pocock of the Department of Epidemiology and Population Health in London on the Diabetologia studies. He claimed that “unnecessary alarm and anxiety” have been created by “claims of harm not backed with adequate evidence”.
