FDA clears Eli Lilly, Boehringer Ingelheim's diabetes combination therapy Glyxambi

The FDA approved Eli Lilly and Boehringer Ingelheim's Glyxambi (empagliflozin/linagliptin) as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes, the companies reported Monday. Eli Lilly noted that Glyxambi "is the first and only diabetes treatment in the US" to combine an SGLT2 inhibitor and a DPP-4 inhibitor in a once-daily tablet taken in the morning.

"Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever," commented Mike Mason, vice president of Eli Lilly's US diabetes unit, adding "the approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition." The therapy was approved at two dosage strengths combining the SGLT2 inhibitor empagliflozin at 10 mg or 25 mg with the DPP-4 inhibitor linagliptin at 5 mg

The approval was supported by data from a Phase III trial that evaluated the efficacy and safety of Glyxambi in comparison with its individual components in 686 adults with type 2 diabetes who were also taking metformin. Results demonstrated that the combination drug showed statistically significant reductions in A1C compared with empagliflozin and linagliptin alone after 24 weeks. Additionally, a greater proportion of Glyxambi-treated patients achieved HbA1c levels of less than 7 percent compared to treatment with either monotherapy.

Glyxambi was co-developed by Eli Lilly and Boehringer Ingelheim under a previously announced diabetes alliance, which was amended in certain markets in October last year. Linagliptin was approved by the FDA in 2011 under the name Tradjenta as a treatment for adults with type 2 diabetes, while empagliflozin was cleared by the FDA last August under the name Jardiance. For related analysis, see ViewPoints: Has Eli Lilly timed the expansion of its diabetes franchise to perfection?

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