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Published on 28 July 2014

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CHMP positive opinion for Xultophy?

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 for Xultophy®, the first-ever once-daily basal insulin (insulin degludec, Tresiba®(1) and GLP-1 analogue (liraglutide, Victoza®)(2) in one pen.
The positive opinion suggests that the licence for Xultophy is just months away. The CHMP positive opinion recommends that Xultophy will be indicated for:
The treatment of adults with type 2 diabetes mellitus to improve glycaemic

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 for Xultophy®, the first-ever once-daily basal insulin (insulin degludec, Tresiba®(1) and GLP-1 analogue (liraglutide, Victoza®)(2) in one pen.
The positive opinion suggests that the licence for Xultophy is just months away. 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(3)
Control of HbA1c is a crucial target in diabetes management. Nearly three quarters of people with type 2 diabetes on basal insulin regimens in the UK fail to reach HbA1c 58mmol/mol (≤7.5%) and are therefore at a greater risk of complications.(4–8) A one percentage point drop in HbA1c can lead to a 37% reduction in microvascular complications, a 14% reduction in myocardial infarctions and a 21% reduction in overall diabetes-related mortality.(7)
“The progressive nature of type 2 diabetes often requires patients to initiate and, over time, intensify insulin therapy in order to keep glucose levels under control,” said Dr Klaus Henning Jensen, Medical Director, UK. “Currently, to intensify their treatment, these patients have the option to increase the dose of basal insulin or add other injectables. Some patients are reluctant to step up their treatment as raising the insulin dose may in turn increase their risk of hypoglycaemia and weight gain – and most of these intensified treatments require more than one injection a day.”
In both the DUAL™ I and II phase IIIa trials in the clinical development programme, Xultophy achieved a significant HbA1c reduction of 1.9%. People treated with Xultophy experienced a low rate of hypoglycaemia, which was comparable to that of Tresiba®, and achieved a reduction in body weight compared with treatment with basal insulin.(9,10)
“The results of these clinical trials provide insight into Xultophy® as a novel, once-daily treatment which delivers real benefits to patients with both a substantial improvement in glycaemic control, as well as a low rate of hypoglycaemia, comparable to Tresiba®. We believe Xultophy® represents a new treatment paradigm in type 2 diabetes, with the potential to address the significant personal and long-term economic burden of this complex condition,” continued Dr Jensen.
Novo Nordisk expects to receive the final marketing authorisation from the European Commission within the coming months.

  1.  Tresiba® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2014.
  2. Victoza® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2014.
  3. 3. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-
  4. _Initial_authorisation/human/002647/WC500170171.pdf (accessed July 2014).
  5.  Blak BT et al. A retrospective database study of insulin initiation in patients with Type 2 diabetes in UK primary care. Diabetic Medicine 2012;29(8):e191–8.
  6. Novo Nordisk Data on File.
  7.  International Diabetes Federation. 2013. Available at: http://www.idf.org/diabetesatlas (accessed 15 July 2014).
  8.  Stratton IM et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study BMJ 2000;321(7258):405–12.
  9. Bethel MA, Feinglos MN, Basal insulin therapy in type 2 diabetes. J Am Board Fam Med 2005;18(3):199–204.
  10. Gough SCL et al. IDegLira, a Novel Fixed Ratio Combination of Insulin Degludec and Liraglutide, is Efficacious and Safe in Subjects with Type 2 Diabetes: A Large, Randomized Phase 3 Trial. Oral presentation (OP 37) at the 49th Annual European Association for the Study of Diabetes (EASD) Congress, 27 September 2013.


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