EMA Advisory Committee Recommends Novo Nordisk’s Insulin CombinationBy
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Xultophy for the treatment of Type 2 diabetes mellitus in adults.
Xultophy is the intended brand name for IDegLira, the first once-daily single injection combination of Tresiba (insulin degludec) and Victoza (liraglutide), developed for the treatment of Type 2 diabetes. The CHMP positive opinion recommends that Xultophy will be indicated for the treatment of adults with Type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control.
Source: Novo Nordisk