Sanofi-aventis welcomes the European Medicines Agency’s statement on Lantus safety

27-Jul-2009 - France

Sanofi-aventis announced that following the review of the available evidence on Lantus® (insulin glargine [rDNA] injection), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed the product’s safety and concluded that changes to the prescribing advice are not necessary.

The 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.

“This is important and reassuring information for patients receiving Lantus®. The clinical usage of Lantus® should continue unchanged”, said Dr. Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. “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.”

Sanofi-aventis will implement a set of actions to develop further research in this area. These actions are in line with recommendations recently made by an independent team of interdisciplinary medical experts on this subject.

Extensive data involving over 70,000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence, and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between insulin glargine and cancer.

https://www.bionity.com/en/news/103795/sanofi-aventis-welcomes-the-european-medicines-agencys-statement-on-lantus-safety.html