Boehringer-Lilly’s diabetes drug fails to receive FDA panel votes

The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted against Boehringer Ingelheim and Eli Lilly’s diabetes drug, empagliflozin. The panel voted 14 to 2, saying that the benefits of 2.5mg dose of the drug do not outweigh its risks as an adjunct to insulin in adults with type 1 diabetes. Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2). In higher doses, the inhibitors were associated with a life-threatening complication, diabetic ketoacidosis (DKA), said Reuters. FDA previously approved 10mg and 20mg empagliflozin (Jardiance) to lower blood sugar levels in patients with type 2 diabetes. The regulator will consider EMDAC’s recommendation while reviewing the drug for type 1 diabetes.