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news.Boehringer Ingelheim Pharmaceuticals (BIPI) and Eli Lilly and Company have received approval from the US Food and Drug Administration (FDA) for Glyxambi tablets to treat adults with type 2 diabetes (T2D).
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Glyxambi is approved as an adjunct to diet and exercise to improve glycemic control in these adults when both empagliflozin and linagliptin are appropriate treatments.
The drug is a combination of 10mg or 25mg of empagliflozin and 5mg of linagliptin and it has not been examined in patients with a history of pancreatitis.
Claimed to be the first and only diabetes treatment in the US, Glyxambi combines the dual 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 taken in the morning.
Lilly Diabetes vice-president Mike Mason said: "Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever.
BIPI president and CEO Paul Fonteyne said: "With Glyxambi, the dual inhibition of DPP-4 and SGLT2 — two proven targets in the treatment of type 2 diabetes — now provides U.S. physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control."
The approval was based on a Phase III trial that evaluated the efficacy and safety of Glyxambi (10/5mg and 25/5mg) compared with the individual components of empagliflozin (10mg or 25mg) or linagliptin (5mg) in adults with T2D who were also taking high-dose metformin.
Around 686 adults with T2D and hemoglobin A1C between 7% and 10.5% were randomized in the trial, which examined the change from baseline in A1C at 24 weeks.
A1C is a measure of average blood glucose over the past two to three months.
The company said that the combination drug is not recommended in patients with type 1 diabetes or to treat diabetic ketoacidosis.
Image: The FDA approval was based on data from the Phase III trial that evaluated the efficacy and safety of Glyxambi. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.