On May 24, 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) unanimously supported, by a vote of 16-Yes to 0-No, with no abstentions, the safety and efficacy of Xultophy (insulin degludec and liraglutide injection) submitted by Novo Nordisk Inc. (Novo), for the proposed indication of adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. Xultophy is a fixed-dose combination of Victoza (liraglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, and Tresiba (insulin degludec), a long-acting insulin analog.
See the SAC Tracker report