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MAA, EU, Boehringer Ingelheim and Eli Lilly and Company announce acceptance of EMA application for investigational Type 2 Diabetes treatment empagliflozin
26 March 2013
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.
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
An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes. Type 2 Diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Empagliflozin is drug which is being investigated in clinical trials for the oral treatment of type 2 diabetes by Boehringer Ingelheim and Eli Lilly and Company. It is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), which is found almost exclusively in the proximal tubules of nephronic components in the kidneys. SGLT-2 accounts for about 90 percent of glucose reabsorption into the blood. Blocking SGLT-2 causes blood glucose to be eliminated through the urine via the urethra.
SGLT-2 inhibitors such as empagliflozin reduce blood glucose by blocking glucose reabsorption in the kidney and thereby excreting glucose (i.e., blood sugar) via the urine.
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