NDA filing for empagliflozin and linagliptin combo accepted by FDA

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational combination tablet of empagliflozin and linagliptin (which is marketed as Tradjenta) for the treatment of adults with type 2 diabetes (T2D) submitted by the US subsidiary of family-owned German drugmaker Boehringer Ingelheim and US pharma major Eli Lilly (NYSE: LLY).

If granted approval by the FDA, this combination will bring together, for the first time into one tablet, the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking 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 FDA acceptance of our filing for the combination tablet of empagliflozin and linagliptin brings us closer to providing patients with type 2 diabetes a potential treatment option that lowers blood sugar through the dual mechanism of action of a DPP-4 inhibitor and an SGLT2 inhibitor," said Christophe Arbet-Engels, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, adding: "Adults living with type 2 diabetes often take more than one therapy to manage their condition, and we hope the combination of these two products will help them improve control of their blood sugar."