The U.S. Food and Drug Administration (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.
“With about 40,000 Americans diagnosed with type 1 diabetes every year, we see today’s meeting as an important means of elevating the discussion around the challenges of managing blood sugar levels for those with type 1 diabetes and the need for new treatment options,”
said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
“We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process.”
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.
“The EASE clinical trial data provides important information supporting the potential role of empagliflozin 2.5 mg for adults with type 1 diabetes,”
said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly.
“Today, less than one third of people with type 1 diabetes in the U.S. consistently meet target blood sugar levels with insulin, putting them at increased risk for long-term complications. We are committed to participating in the ongoing dialogue around improving patient health and treatment options for this community.”
Advisory committees provide the FDA with independent opinions and recommendations from outside medical experts during the drug review process. The FDA is not obligated to follow their recommendation, but it often does.