FDA Accepts NDA for Empagliflozin-Metformin Combination

The FDA has accepted filing of a new drug application (NDA) for a fixed-dose combination of empagliflozin plus immediate-release metformin hydrochloride for treatment of adults with type 2 diabetes, according to a press release from Boehringer Ingelheim and Eli Lilly.

Clinical trial data evaluating co-administration of empagliflozin and metformin in 4,740 adults with type 2 diabetes are included in the filing.

The FDA approved empagliflozin tablets, marketed as Jardiance, in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug is not currently recommended for type 1 diabetes or treatment of diabetic ketoacidosis.

“Type 2 diabetes is a progressive condition, and many patients eventually require multiple medications to manage their blood sugar,” Christophe Arbet-Engels, MD, PhD, vice president of metabolic-clinical development and medical affairs at Boehringer Ingelheim, said in the release.

“The FDA’s acceptance of the NDA for the empagliflozin plus metformin fixed-dose combination brings us one step closer to offering a potential new treatment option that may help patients better manage their type 2 diabetes through one pill that combines two distinct approaches to help control blood sugar.”