Boehringer and Eli Lilly announce outcome of FDA advisory committee meeting for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes. Empagliflozin 2.5 mg is an SGLT2 inhibitor being developed by Boehringer Ingelheim and Eli Lilly and Company . A separate brand name has been proposed for empagliflozin 2.5 mg in type 1 diabetes.

The supplemental New Drug Application (sNDA) included data from the EASE (Empagliflozin as Adjunctive to inSulin thErapy) phase III program, which found that empagliflozin 2.5 mg in combination with insulin provided a statistically significant reduction in A1C (0.28%) versus insulin given with a matched placebo in adults with type 1 diabetes. Secondary endpoints of the trial demonstrated reductions in weight (1.8 kg) and systolic blood pressure (2.1 mmHg), compared to insulin plus placebo. Adverse events occurred with similar frequency among patients treated with empagliflozin 2.5 mg in combination with insulin, compared to those treated with insulin plus placebo. The number of diabetic ketoacidosis events was comparable between empagliflozin 2.5 mg in combination with insulin and insulin plus placebo.