FDA Approves New Type 2 Diabetes Treatment

The FDA today approved Boehringer Ingelheim and Lilly’s empagliflozin and linagliptin (Glyxambi) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) who can be treated with both of the drug’s active ingredients individually.

With this FDA nod, Glyxambi becomes the first and only diabetes treatment in the United States to combine the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, and a dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin.

“Today's medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control,” said Paul Fonteyne, Boehringer Ingelheim president and CEO, in a press release. “With Glyxambi, the dual inhibition of DPP-4 and SGLT2—2 proven targets in the treatment of T2D—now provides US physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control.”

The FDA based its approval on the results of a phase 3 clinical trial that evaluated the efficacy and safety of once-daily Glyxambi (10/5 mg and 25/5 mg) in 686 adults with T2D who were taking high-dose metformin and had a hemoglobin A1C between 7.0-10.5%. The research team found that, at 24 weeks, trial patients achieved a mean A1C of 6.9% and 6.7% with Glyxambi 10/5 mg and 25/5 mg, respectively, compared with a mean A1C of 7.3% with empagliflozin 10 mg, 7.4% with empagliflozin 25 mg, and 7.3% with linagliptin 5 mg.

“Half of people with T2D do not achieve recommended blood sugar control, making new treatment options more important than ever,” said Mike Mason, vice president of Lilly Diabetes. “The approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition.”

The most common adverse reactions reported by trial patients treated with Glyxambi were urinary tract infection, nasopharyngitis, and upper respiratory tract infection.