Boehringer Ingelheim and Eli Lilly and Company announce acceptance of European marketing authorisation application for investigational Type 2 Diabetes treatment empagliflozin
European Medicines Agency has accepted for review a marketing authorisation application for the sodium glucose cotransporter-2, empagliflozin
EX US & UK Medical Media Only
Ingelheim, Germany, 26 March 2013 - 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.
Corporate Senior Vice
President Medicine,
Boehringer Ingelheim
"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.
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
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three compounds representing several of the largest treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or http://www.lilly.com/Pages/Home.aspx
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act with social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
About Eli Lilly and Company
Lilly, a leading innovation driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/Pages/Home.aspx.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions - from medicines to support programs and more - to make lives better http://www.lillydiabetes.com/
For more information, visit .
This press release contains forward-looking statements about empagliflozin* tablets for the treatment of type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that empagliflozin* will prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Footnotes
*Empagliflozin is an investigational compound. Its safety and efficacy have not yet been fully established
Referências
- 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.