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Boehringer Ingelheim. (3/21/14). "Press Release: Type 2 Diabetes – CHMP Recommends Empagliflozin for Approval [For Non-US and Non-UK Media]". Ingelheim & Indianapolis, IN.

Region Region EU (European Union)
Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 CHMP (Committee for Medicinal Products for Human Use) (EU)
  Group EU (govt)
Product Product empagliflozin
Index term Index term Lilly–Boehringer: antidiabetic drugs, 201101– collab strategic alliance ww joint developm + marketing of portfolio of diabetes drugs
Person Person Dugi, Klaus (Boehringer 201106 Corporate SVP Medicine)
     


For Non-US and Non-UK Media


Positive opinion for investigational SGLT2 inhibitor empagliflozin for the treatment of T2D in adults


Boehringer Ingelheim and Eli Lilly and Company are pleased to announce a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of the investigational sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin* (if approved to be marketed under the name Jardiance®) for the treatment of adults with Type 2 Diabetes (T2D).

Empagliflozin is an investigational compound that belongs to the SGLT2 inhibitor class of drugs that targets glucose directly and works independently of ß-cell function and insulin resistance.1, 2 Following the CHMP positive opinion, the European Commission generally follows the recommendation and usually issues its final decision for marketing authorisation within two months.3

"The CHMP positive opinion brings us a step closer to having a potential new treatment option in Europe for people with Type 2 Diabetes," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "If approved, empagliflozin would be the third product approved in Europe as part of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance."

An estimated 382 million people worldwide have Type 1 or Type 2 Diabetes.4 T2D is the most common type, accounting for 85-95 percent of diabetes cases in high-income countries.4 Although a range of treatments exist to manage the condition, 50 percent of people do not achieve their glycaemic targets.5


About Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company entered into an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find more information about the alliance at www.boehringer-ingelheim.com or www.lilly.com


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 140 affiliates and more than 46,000 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2012, Boehringer Ingelheim achieved net sales of about €14.7 billion. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com


About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.


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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions-from medicines to support programs and more-we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.


This press release contains forward-looking statements about empagliflozin 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 commercialization. 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.

* Empagliflozin is an investigational compound. Its safety and efficacy have not yet been fully established


References:

1 Ferrannini E, et al. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014;124(2):499-508.
2 DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012;14(1):5-14.
3 EMA. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/q_and_a/q_and_a_detail_000114.jsp (accessed: 17 February).
4 International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation; 2013.
5 Teoh H, Home P, Leiter LA. Should A1C targets be individualized for all people with diabetes? Arguments for and against. Diabetes Care. 2011;34 Suppl 2:S191-6.


Media contact

Boehringer Ingelheim
Media & PR
Marco Winkler
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY
Phone +49/6132/77 90013
Fax +49/6132/77 6601

Media contact

Eli Lilly and Company
Communications Manager
Lilly Diabetes
Tammy Hull
Phone +1 (317) 651-9116

   
Record changed: 2017-04-02

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