Novo Nordisk receives positive opinion on Xultophy® (IDegLira) from the European regulatory authorities
2014-07-25 · Novo Nordisk A/S · original novonordisk.com ↗
Bagsværd, Denmark, 25 July 2014 - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorisation 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. For further information Media: Lars Pallisgaard +45 3079 3730 [email protected] Ken Inchausti (US) +1 609 514 8316 [email protected] Investors: Kasper Roseeuw Poulsen +45 3079 4303 [email protected] Jannick Lindegaard Denholt +45 3079 8519 [email protected] Daniel Bohsen +45 3079 6376 [email protected] Frank Daniel Mersebach (US) +1 609 235 8567 [email protected] Company Announcement No 45 / 2014
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