First-in-class type 2 diabetes treatment GLYXAMBI tablets for adults now available in U.S. pharmacies

GLYXAMBI® (empagliflozin/linagliptin) tablets are now available by prescription in the U.S. from many leading chain and independent pharmacies.

GLYXAMBI, part of the Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Diabetes alliance portfolio, is the first and only dual inhibitor combination therapy approved in the U.S. to combine the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet.

GLYXAMBI is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.

GLYXAMBI gives adults with type 2 diabetes a new option to help improve blood sugar control

"The rapid market availability of GLYXAMBI following its recent FDA approval in late January is a reflection of Boehringer Ingelheim and Lilly's commitment to bringing new treatment options to people with type 2 diabetes," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "As the fourth diabetes medicine to emerge from our alliance pipeline in the U.S., we believe GLYXAMBI may help adults with type 2 diabetes lower their blood sugar and manage their diabetes."

"As an add-on to metformin, GLYXAMBI was superior in reducing A1C when compared with either empagliflozin or linagliptin alone," said David Kendall, M.D., vice president, medical affairs, Lilly Diabetes. "The management of type 2 diabetes requires a personalized treatment plan, and GLYXAMBI provides patients and their physicians with a new option to help improve blood sugar control."

The U.S. Food and Drug Administration approval was based on a phase III clinical trial that evaluated the efficacy and safety of GLYXAMBI (10/5 mg and 25/5 mg) compared with the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with T2D who were also taking high-dose metformin (mean dose 1889 mg daily). The study, which randomized 686 adults with T2D and hemoglobin A1C (a measure of average blood glucose over the past two to three months) between 7.0 and 10.5 percent, examined the change from baseline in A1C at 24 weeks. The study demonstrated superior A1C reduction with GLYXAMBI compared with the individual components of empagliflozin or linagliptin. Starting from a mean baseline of approximately 8.0 percent, adults in this trial achieved a mean A1C of 6.9 and 6.7 percent with GLYXAMBI 10/5 mg and 25/5 mg, respectively, compared with a mean A1C of 7.3 and 7.4 percent for empagliflozin 10 mg and 25 mg, respectively, and 7.3 percent for linagliptin 5 mg.

Data recently published in Diabetes Care demonstrated that 58 percent and 62 percent of patients taking GLYXAMBI 10/5 mg or 25/5 mg, respectively, in addition to metformin achieved an A1C of less than 7 percent from a baseline A1C of approximately 8 percent, compared with 28 percent of patients taking empagliflozin 10 mg, 33 percent taking empagliflozin 25 mg and 36 percent taking linagliptin 5 mg.

Through 52 weeks, the safety profile of GLYXAMBI was demonstrated in a pooled analysis, and the most common adverse reactions were urinary tract infection (UTI) (12.5 percent and 11.4 percent for GLYXAMBI 10/5 mg and 25/5 mg, respectively; through 52 weeks, no patient discontinued GLYXAMBI due to UTIs), nasopharyngitis (5.9 percent and 6.6 percent for GLYXAMBI 10/5 mg and 25/5 mg, respectively) and upper respiratory tract infection (7.0 percent for GLYXAMBI 10/5 mg and 25/5 mg).

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