When was Glyxambi (empagliflozin and linagliptin) first approved by the FDA (Food and Drug Administration) in the U.S.?

When Was Glyxambi First Approved in the U.S.?

Glyxambi (empagliflozin/linagliptin) was first approved by the FDA in the United States in 2015. 1

Background on Glyxambi

• Glyxambi was the first fixed-dose combination product containing an SGLT2 inhibitor (empagliflozin) and a DPP-4 inhibitor (linagliptin) approved in the United States 1
• This medication is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and linagliptin is appropriate 1
• The combination provides dual mechanisms of action: empagliflozin blocks glucose reabsorption in the kidneys while linagliptin inhibits DPP-4 to increase incretin levels 2

Clinical Significance of Glyxambi

• Clinical trials demonstrated that empagliflozin/linagliptin improved glycemic control significantly more than either component alone when used as initial therapy or as add-on therapy to metformin 1
• In addition to glycemic control, the combination provides significant weight loss compared to linagliptin alone 1
• The fixed-dose combination helps reduce pill burden, which may improve medication adherence in patients with type 2 diabetes 3

Component Medications

• Empagliflozin (one component of Glyxambi) has demonstrated significant cardiovascular benefits, including a 38% reduction in cardiovascular death in the EMPA-REG OUTCOME trial 4
• Linagliptin (the other component) is a DPP-4 inhibitor that has been studied in cardiovascular outcomes trials such as CARMELINA, showing cardiovascular safety 5

Evolution of Diabetes Combination Therapies

• Since Glyxambi's approval in 2015, additional combination therapies have been developed, including a triple fixed-dose combination of empagliflozin, linagliptin, and extended-release metformin approved by the FDA 6
• The development of fixed-dose combinations represents a trend toward simplifying complex medication regimens for patients with type 2 diabetes 7

Practical Considerations

• Glyxambi is part of the broader trend of developing combination therapies to address the progressive nature of type 2 diabetes and to improve medication adherence 2
• When considering cost, fixed-dose combinations like Glyxambi may provide a more cost-effective option compared to taking the individual components separately 3