Novo Nordisk A/S: Novo Nordisk receives positive opinion on Xultophy(r) (IDegLira) from the European regulatory authorities
Bagsvaerd, Denmark, Jul 25, 2014 (GLOBE NEWSWIRE via COMTEX) --
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
Lars Pallisgaard +45 3079 3730 [email protected]
Ken Inchausti (US) +1 609 514 8316 [email protected]
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
Company Announcement No 45 2014 http://hugin.info/2013/R/1837250/638603.pdf
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