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Main » 2013 » March » 27 » Boehringer Ingelheim and Eli Lilly and Company announce acceptance of European marketing authorisation application for investigational Type
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Boehringer Ingelheim and Eli Lilly and Company announce acceptance of European marketing authorisation application for investigational Type
European Medicines Agency has accepted for review a marketing authorisation application for the sodium glucose cotransporter-2, empagliflozin

INGELHEIM, Germany - Wednesday, March 27th 2013 [ME NewsWire]

(BUSINESS WIRE)--

EX US & UK Medical Media Only

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

~ends~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/26_march_2013_empagliflozin.html

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

Contacts

Ute E. Schmidt

Launch and Established Products CVM

Boehringer Ingelheim GmbH

Email: press@boehringer-ingelheim.com

Phone: +49 (6132) 77-97296

 

OR

Tammy Hull

Communications Manager

Lilly Diabetes

Email: hullta@lilly.com

Phone: +1 (317) 651-9116

 
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