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news.The US Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for Boehringer Ingelheim and Eli Lilly's investigational combination tablet of empagliflozin and linagliptin to treat adults with type 2 diabetes (T2D).
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If FDA approves the combination tablet, it will bring together the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor.
The company said that SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney, while DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
Boehringer Ingelheim Pharmaceuticals vice president of metabolic-clinical development and medical affairs Christophe Arbet-Engels said the FDA acceptance of the company’s filing for the combination tablet of empagliflozin and linagliptin brings it 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.
"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," Arbet-Engels said.
The NDA follows the completion of a Phase III clinical registration trial designed to assess the efficacy and safety of the empagliflozin/linagliptin combination compared to the individual components in adults with T2D.
The Boehringer Ingelheim and Lilly Diabetes alliance intend to release the Phase III trial results later in 2014.
Linagliptin, marketed as Tradjenta (linagliptin) tablets in the US, is a once-daily, 5mg tablet used along with diet and exercise to improve glycemic control in adults with T2D.
The drug should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis and it has not been studied in patients with a history of pancreatitis.