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Published on 25 March 2014

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CHMP recommends empagliflozin for approval for type 2 diabetes

 

 

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 % of diabetes cases in high-income countries.(4) Although a range of treatments exist to manage the condition, 50% of people do not achieve their glycaemic targets.(5)
*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.


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