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# FDA Rejects Boehringer/Lilly Diabetes NDA
- URL: https://www.fdaweb.com/fda-rejects-boehringer-lilly-diabetes-nda/
- Published: 2020-03-20T12:00:00.000Z
- Updated: 2026-09-14T16:08:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146383

FDA has issued Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empagliflozin 2.5 mg and its use as an adjunct to insulin for adults with Type 1 diabetes. The letter states that the agency is unable to approve the application in its current form, “consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee in November.” That panel voted 14 to 2 to not recommend the drug’s approval because its benefits did not outweigh its risks. The SGLT2 inhibitor is currently approved as Jardiance in 10 mg and 20 mg for lowering blood sugar levels in patients with Type 2 diabetes. The companies note that a separate brand name has been proposed for empagliflozin 2.5 mg in Type 1 diabetes.

Panel members expressed concern that SGLT2 inhibitors have been associated with risks of diabetic ketoacidosis (DKA) in higher doses. DKA occurs when the body starts breaking down fat at a rate that is much too fast. The liver processes the fat into a fuel called ketones, which causes the blood to become acidic. The panel recommended an additional study to determine safety risks.