Novo Nordisk
2014-07-25T11:30:24Z
2014-07-25T11:30:24Z
Novo Nordisk receives positive opinion on Xultophy® (IDegLira) from the European regulatory authorities
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 | lplg@novonordisk.com |
| Ken Inchausti (US) | +1 609 514 8316 | kiau@novonordisk.com |
| Investors: | ||
| Kasper Roseeuw Poulsen | +45 3079 4303 | krop@novonordisk.com |
| Jannick Lindegaard Denholt | +45 3079 8519 | jlis@novonordisk.com |
| Daniel Bohsen | +45 3079 6376 | dabo@novonordisk.com |
| Frank Daniel Mersebach (US) | +1 609 235 8567 | fdni@novonordisk.com |
Company Announcement No 45 / 2014