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FDA to review empagliflozin/linagliptin tablet for treating type 2 diabetes
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The FDA has accepted the filing of an application for a new drug from Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals Inc. for the combination tablet of empagliflozin and linagliptin, which will help control blood glucose in adults with type 2 diabetes.
The filing follows the completion of a phase 3 clinical trial by Lilly and Boehringer Ingelheim; the Lilly Diabetes Alliance and Boehringer Ingelheim plan to publish data from that study later this year.
The tablet combines the mechanisms of action of a sodium-glucose cotransporter 2 inhibitor and a DPP-IV inhibitor. DPP-IV inhibitors increase hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose. SGLT2 inhibitors stimulate the removal of excess glucose via urination by blocking glucose reabsorption in the kidneys.
“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-IV inhibitor and an SGLT2 inhibitor,” Christophe Arbet-Engels, MD, PhD, vice president of metabolic-clinical development and medical affairs at Boehringer Ingelheim, said in a press release.
“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 two pharmaceutical companies first announced their collaboration on new diabetes research in January 2011.
Lilly and Boehringer Ingelheim’s new drug application follows a study recently published in The Lancet Diabetes & Endocrinology that showed improved blood glucose maintenance through use of the glucagon-like peptide-1 receptor agonist exenatide (Byetta, Amylin).
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Diamant M. Lancet Diabetes Endocrinol. 2014;doi:10.1016/S2213-8587(14)70029-4.