Panel Nixes Lilly/Boehringer Diabetes Drug

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 14 to 2 to not recommend approval of Eli Lilly and Boehringer Ingelheim’s empagliflozin 2.5 mg because the drug’s benefits do not outweigh its risks as an adjunct to insulin for adults with Type 1 diabetes. 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.