Type 2 Diabetes: CHMP Recommends Empagliflozin* for Approval

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

INGELHEIM, Germany & INDIANAPOLIS, US - Friday, March 21st 2014 [ME NewsWire]

(BUSINESS WIRE) Non-US and Non-UK Media

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 β-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

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

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/21_march_2014_empagliflozin.html

Contacts
Boehringer Ingelheim GmbH
Marco Winkler
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (151) 689 46812



Lilly Diabetes
Tammy Hull
Communications Manager
Email: hullta@lilly.com
Phone: +1 (317) 651 9116






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