Following the review of the available evidence on Sanofi-aventis’ Lantus (insulin glargine [rDNA] injection), the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) has confirmed the product’ safety. It also concluded that changes to the prescribing advice are not necessary.
EMEA issued a press-release stating that they have re-confirmed their initial assessment, based on an in-depth review of existing evidence and of the recent publications of registry analyses in Diabetologia. All four registry analyses were found to have significant methodological limitations, and to provide inconsistent and inconclusive results regarding a potential link between Lantus use and an increased risk of cancer.
Jean-Pierre Lehner, chief medical officer of Sanofi-aventis, said: “This is important and reassuring information for patients receiving Lantus. The clinical usage of Lantus should continue unchanged. 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.”