Eli Lilly, Boehringer Ingelheim Receive EU Approval for Diabetes Drug Empagliflozin

The European Commission has granted marketing authorization for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, from Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin has been approved for the treatment of Type 2 diabetes to improve glycaemic control in adults and will be marketed in Europe as Jardiance.

The European Commission approved empagliflozin 10 and 25 mg once-daily tablets for use when diet and exercise alone do not provide adequate glycaemic control: alone when metformin is not considered appropriate due to intolerance and alongside other glucose-lowering medicines including insulin when glucose control is inadequate.

SGLT2 inhibitors are a new class of  diabetes drugs. SGLT2 are proteins fundamental to the kidney's role in filtering blood sugar and are responsible for about 90% of the reabsorption of glucose back into the bloodstream. In people with Type II diabetes, there is an overexpression of SGLT2, contributing to elevated blood glucose levels. Empagliflozin reduces the kidneys' ability to reabsorb glucose into the bloodstream, leading to urinary glucose excretion. Unlike most classes of existing oral Type 2 diabetest treatments, SGLT2 inhibitors, such as empagliflozin, work independently of β-cell function and insulin pathway.

Johnson & Johnson’s Janssen Pharmaceuticals' Invokana (canaglifozin) and AstraZeneca’ Farxiga/Forxiga (dapaglifozin) are two other commercial SGLT2 inhibitors. Farxiga was approved by the FDA in January 2014. It was approved in Europe, where it is marketed as Forxiga, in November 2012 and in Japan in March 2014. Janssen Pharmaceuticals' Invokana received US and European markeing approval in 2013.  

Empagliflozin is the third drug coming from the diabetes alliance between Eli Lilly and Boehringer Ingelheim; the companies formed the alliance in January 2011. In April 2014, Boehringer Ingelheim and Eli Lilly reported that the FDA accepted the filling of a new drug application for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with Type 2 diabetes. Boehringer Ingelheim’s linagliptin, marketed as Tradjenta, was approved by FDA in 2011, and is a  once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with Type II diabetes. If granted approval by the FDA, this combination brings together in one tablet the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor (empagliflozin)  and a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin). SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

In March 2014, Boehringer Ingelheim and Eli Lilly and Company received a complete response letter from the FDA for their new drug application for empagliflozin. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. FDA stated these deficiencies need to be resolved before the approval of the application. FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

See related article, “AstraZeneca Leading the Way For New Drug Approvals in 2014″

Source: Boehringer Ingelheim and Eli Lilly

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