Boehringer Ingelheim and Eli Lilly and Company announce acceptance of EMA application for investigational Type 2 Diabetes treatment empagliflozin*
Posted: 26 March 2013 | | No comments yet
“We are pleased with the promising results…”
Boehringer Ingelheim and Eli Lilly and Company today announced the European Medicines Agency (EMA) has accepted for review a marketing authorisation application (MAA) for the investigational sodium glucose cotransporter-2 (SGLT2) inhibitor, empagliflozin, for the treatment of Type 2 Diabetes (T2D) in adults. The acceptance of the MAA marks the beginning of the review process in the European Union for this potential oral diabetes treatment.
“We are pleased with the promising results shown in clinical trials of empagliflozin and are delighted that EMA has accepted our marketing authorisation application,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Type 2 Diabetes is a critical health issue and new treatment options are needed in order to help patients better manage their condition.”
A New Drug Application (NDA) for empagliflozin was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of Type 2 Diabetes mellitus (T2D) in adults.
Empagliflozin is part of a class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. In clinical trials to date, SGLT2 inhibitors have been shown to reduce blood glucose by removing excess glucose independently of beta cell function and insulin resistance.
* Empagliflozin is an investigational compound. Its safety and efficacy have not yet been fully established
About Diabetes
An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes.1 Type 2 Diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.2 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.3
REFERENCES
- International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
- World Health Organization. 2009. Available from www.who.int/mediacentre/factsheets/fs312/en/print.html Accessted February 2013
- International Diabetes Federation. What is Diabetes IDF Website – IDF DIABETES ATLAS 5th edition. 2012.
