Type 2 Diabetes: CHMP recommends empagliflozin* for approval
Positive opinion for investigational SGLT2 inhibitor empagliflozin for the treatment of T2D in adults
Ingelheim, Germany and Indianapolis, US, 21 March 2014 - 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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