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Pharmaceutical industry

FDA Approves Glyxambi for Type 2 Diabetes Management

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) has approved Glyxambi, a new medication combination developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, to improve glycemic control in adults with type 2 diabetes. This innovative treatment combines the dual mechanisms of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor, marking the first and only diabetes treatment of its kind in the U.S. Glyxambi has been shown to provide significantly greater reductions in blood glucose levels compared to either empagliflozin or linagliptin alone.

Key Takeaways:

  • The FDA has approved Glyxambi, a combination of empagliflozin and linagliptin, for the treatment of type 2 diabetes in adults.
  • Glyxambi is the first and only diabetes treatment to combine the dual mechanisms of action of a SGLT2 inhibitor and a DPP-4 inhibitor in a once-daily tablet.
  • The medication has been shown to provide significant reductions in blood glucose levels in patients uncontrolled on metformin, compared to either component used alone.
  • Patients with severe renal impairment, end-stage renal disease, or dialysis should not take Glyxambi, as well as those with a history of hypersensitivity reactions to linagliptin or empagliflozin.
  • Postmarketing reports have noted cases of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin, a component of Glyxambi.

Statistics:

  • Half of people with type 2 diabetes do not achieve recommended blood sugar control.
  • Glyxambi has been shown to provide significantly greater reductions in blood glucose levels compared to either empagliflozin or linagliptin alone: 9.8 mmol/L (176.2 mg/dL) vs. 7.4 mmol/L (133.6 mg/dL) and 8.3 mmol/L (148.9 mg/dL), respectively.
  • The U.S. market for type 2 diabetes treatments is large, with millions of patients in need of effective management options.

Sources:

  • Food and Drug Administration (FDA)
  • Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
  • Eli Lilly and Company (NYSE: LLY)
  • NewsRx LLC.

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