BI And Lilly File NDA For Combination Tablet For Type 2 Diabetes
Boehringer Ingelheim and Eli Lilly & Co. announced the filing of a New Drug Application (NDA) for the investigative combination tablet empagliflozin and linagliptin for the treatment of adult patients with Type 2 diabetes.
The U.S. Food and Drug Administration (FDA) has accepted the filing for the combination tablet. If approved, the companies say that empagliflozin/linagliptin will bring together two distinct mechanisms of action for the first time in one tablet. First will be sodium glucose co-transporter-2 (SGLT2) inhibitor’s removal of excess glucose through the urine by blocking glucose re-absorption in the kidney. Second is dipeptidyl peptidase-4 (DPP-4) inhibitor’s activity in increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose.
Christophe Arbet-Engels, VP of the metabolic-clinical development and medical affairs at Boehringer Ingelheim, said, “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. 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.”
Tradjenta tablet (linagliptin) is a once-daily, 5 mg tablet used in conjunction with diet and exercise to improve glycemic control in adults with Type 2 diabetes. An estimated 382 million people worldwide and about 24.4 million Americans have Type 1 or Type 2 diabetes.
The companies’ filing for Tradjenta is based on the completion of a Phase II clinical registration trial assessing the safety and efficacy of empagliflozin/linagliptin combination compared to its individual components in adults with Type 2 diabetes. The Boehringer Ingelheim and Lilly Diabetes partnership announced plans to present data from the study later in 2014.