Sanofi-aventis drug wins EMA clearance
Dubai, July 25, 2009
Sanofi-aventis, a leading global pharmaceutical company, has confirmed that changes to the prescribing advice of its new insulin injection are not necessary following a review of the drug by a committee of the European Medicines Agency (EMA).
EMA’s Committee for Medicinal Products for Human Use (CHMP) has reportedly confirmed the safety of Sanofi-aventis’ Lantus (insulin glargine [rDNA] injection).
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,” said Dr Jean-Pierre Lehner, chief medical officer, sanofi-aventis.
“The clinical usage of Lantus should continue unchanged,” he added.
“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. – TradeArabia News Service