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FDA advisory committee votes down approval of Boehringer and Lilly's drug for type 1 diabetes

Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), after the independent panel voted against the use of the pair’s SGLT2 inhibitor empagliflozin (branded as Jardiance) as an add-on insulin therapy in the treatment of type 1 diabetes.

The drug is already approved, with the FDA passing approval in 2014 for the reduction of blood sugar levels in type 2 diabetes patients.

Jardiance scores more cardiovascular outcomes data

Boehringer Ingelheim and Lilly co-market Jardiance for type 2 diabetes

A sub-group analysis of data from an outcomes study of Boehringer Ingelheim’s and Lilly’s Jardiance has found the diabetes drug reduces the risk of heart failure outcomes by 39%.

Earlier this year the two companies in the diabetes alliance presented preliminary data from the EMPA-REG OUTCOMES trial, which was the first to find that a blood sugar-lowering drug could reduce the risk of cardiovascular events.

More positive CV data for Boehringer and Lilly’s Jardiance


Jardiance, an anti-diabetes drug produced by Boehringer Ingelheim and Eli Lilly, reduces the risk of death in people with type 2 diabetes, according to the results of a Phase III study.

The results of the EMPA-REG OUTCOME trial found Jardiance (empagliflozin) had a statistically significantly 14% lower rate of the primary outcome – death from cardiovascular causes – when the study drug was added to standard care, compared to treatment with standard care alone.

Boehringer assures future growth following sales drop

Boehringer image

Boehringer says it is positioned for future growth in the wake of filing a decline in profit for 2014 and flat earnings.

Its latest annual financial statement reports that net income dropped 21% to €1.05 billion ($1.13 billion) last year from €1.32 billion in fiscal 2013. Global sales declined 5.3% to €13.3 billion. Full-year operating profit came in at €2.1 billion the German family-owned group notes.

Boehringer and Lilly score FDA yes for Glyxambi

Glyxambi image

The FDA has approved Glyxambi (empagliflozin/linagliptin), which has become the first combination of two diabetes drugs in their different classes to go on sale in the US.

Glyxambi combines Boehringer Ingelheim’s Jardiance (empagliflozin) with Lilly’s Tradjenta (linagliptin). Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor and Tradjenta is a dipeptidyl peptidase-4 (DPP-4) inhibitor.

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