Boehringer and Lilly score FDA yes for Glyxambi

The FDA has approved Glyxambi (empagliflozin/linagliptin), which has become the first combination of two diabetes drugs in their different classes to go on sale in the US.

Glyxambi combines Boehringer Ingelheim’s Jardiance (empagliflozin) with Lilly’s Tradjenta (linagliptin). Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor and Tradjenta is a dipeptidyl peptidase-4 (DPP-4) inhibitor.

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.

The Glyxambi combination is a once-daily tablet taken in the morning and has been approved for use as an additional treatment along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes for whom empagliflozin and linagliptin are appropriate treatments.

"Today's medical community recognises the need to treat type 2 diabetes from multiple fronts to help patients improve glycaemic control," says Paul Fonteyne, president and chief executive of Boehringer Ingelheim.

"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 glycaemic control.

Mike Mason, vice president of Lilly Diabetes US adds: "Half of people with type 2 diabetes do not achieve recommended blood sugar control, making new treatment options more important than ever.

"The approval of Glyxambi gives US physicians and patients a first-in-class prescription medicine to help manage this condition."

The decision came as Sanofi’s inhaled insulin Afrezza was also signed-off for sale in the US by the FDA for people with type 1 and type 2 diabetes.

Lilian Anekwe