The US Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company 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 is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

Glyxambi is the first and only diabetes treatment in the US to combine 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. Glyxambi combines 10 mg or 25 mg of empagliflozin with 5 mg of linagliptin. SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

"Today's medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control," said Paul Fonteyne, president and chief executiveofficer, BIPI. "With Glyxambi, the dual inhibition of DPP-4 and SGLT2 two proven targets in the treatment of type 2 diabetes now provides US physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control. For patients uncontrolled on metformin, phase III trial results showed Glyxambi provided significantly greater reductions in blood glucose levels compared with either empagliflozin or linagliptin alone."

Glyxambi should not be taken by patients with severe renal impairment, end-stage renal disease or dialysis; a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity; or history of serious hypersensitivity reaction to empagliflozin. There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin, a component of Glyxambi. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Glyxambi and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Glyxambi.

"Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever," says Mike Mason, vice president, US, Lilly Diabetes. "The approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition. The approval is also a testament to our alliance's commitment to adults living with type 2 diabetes."

The FDA 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 randomised 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 per cent, examined the change from baseline in A1C at 24 weeks.

In the study, as an add-on to metformin, Glyxambi showed statistically significant reductions in A1C compared with empagliflozin and linagliptin alone at 24 weeks. 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.

The percentage of patients achieving an A1C less than 7 percent with Glyxambi 10/5 mg or 25/5 mg was 58 per cent and 62 per cent, respectively, compared with 28 per cent, 33 per cent and 36 per cent for empagliflozin 10 mg, empagliflozin 25 mg and linagliptin 5 mg, respectively.

Although not approved for lowering weight, Glyxambi provided significant weight loss at 24 weeks compared with linagliptin alone.

Glyxambi 10/5 mg: average body weight reduction of 3.1 per cent from an average baseline of 191 lbs Glyxambi 25/5 mg: average body weight reduction of 3.4 per cent from an average baseline of 187 lbs, Linagliptin 5 mg: average body weight reduction of 0.7 per cent from an average baseline of 187 lbs, Through 52 weeks, the overall incidence of hypoglycemia with Glyxambi was 2.2 per cent and 3.6 percent for Glyxambi 10/5 mg and 25/5 mg, respectively, and there were no cases of severe hypoglycemia reported in the trial. A lower dose of an insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with Glyxambi.

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 per cent and 11.4 per cent for Glyxambi 10/5 mg and 25/5 mg, respectively; through 52 weeks, no patient discontinued Glyxambi due to UTIs, Nasopharyngitis: 5.9 per cent and 6.6 per cent for Glyxambi 10/5 mg and 25/5 mg, respectively, upper respiratory tract infection: 7.0 percent for Glyxambi 10/5 mg and 25/5 mg

Glyxambi is a prescription medicine that contains 2 diabetes medicines, empagliflozin and linagliptin.  Glyxambi can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both empagliflozin and linagliptin is appropriate.

Glyxambi is not for people with type 1 diabetes or for diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas) it is not known if you have a higher chance of getting pancreatitis while taking Glyxambi.

Approximately 29 million Americans and an estimated 387 million people worldwide have type 1 or type 2 diabetes, and nearly 28 percent of Americans with diabetes totalling 8 million people are undiagnosed. In the US, approximately 12 percent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 per cent of all adult diabetes cases in the US Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.