NOVO NORDISK A/S
Copenhagen, Denmark, 21 November 2014 - The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza®, the once-daily human glucagon-like peptide-1 (GLP-1) analogue, to adults with type 2 diabetes and moderate renal impairment without dose adjustments.
Renal impairment is a challenging and common long-term complication of type 2 diabetes that requires frequent monitoring of blood glucose levels and kidney function. Depending on age, duration of diabetes and blood glucose control, up to 40% of people with type 2 diabetes will develop some degree of renal impairment.1
"Renal impairment is very common in patients with type 2 diabetes, and the choice of glucose-lowering therapies available to people with both conditions is limited", said Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre, University of Leicester, UK and clinical trial investigator. "This label update gives physicians an additional treatment option to help their patients with type 2 diabetes and moderate renal impairment achieve glycaemic control."
The CHMP recommendation for Victoza® was based on efficacy and safety data from the
LIRA-RENAL phase 3b clinical trial.
The 26-week, double-blind, randomised, controlled study investigated the efficacy and safety of Victoza® compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof in adults with type 2 diabetes and moderate renal impairment.2
Study results include:3
Corporate Communications
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Internet: www.novonordisk.com CVR no:
24 25 67 90
ZINC ID#: HQMMA/VT/1114/0468Date of Approval: November - 2014
Page 2 of 3
The addition of once-daily Victoza® versus placebo in adults with type 2 diabetes and moderate renal impairment showed statistically significantly greater reduction in mean HbA1c (-1.05% vs. -0.38%) and body weight (-2.41 kg vs -1.09 kg)
Adults treated with Victoza® experienced no change in renal function (estimated
glomerular filtration rate [eGFR] (Modification of Diet in Renal Disease [MDRD])
change from baseline: liraglutide -1%; placebo +1%)
There was a comparable risk of hypoglycaemic episodes between the two treatment groups. The safety profile of Victoza® was generally similar to that observed in other studies of the treatment
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose- dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia†. In addition, Victoza® reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake. Victoza® is not
approved for weight management or for use in people who do not have type 2 diabetes.
Victoza® was launched in the EU in 2009 and is commercially available in more than 70 countries with more than 2.3 million patient years of exposure in people with type 2 diabetes globally. In Europe, Victoza® is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.4 In the US, Victoza® was approved on 25 January 2010 as
an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.5
† Hypoglycaemia has primarily been observed when Victoza® is combined with a sulfonylurea.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately
41,000 employees in 75 countries, and markets its products in more than 180 countries. For more
information, visit novonordisk.com.
Further information Media: Katrine Sperling | +45 4442 6718 | krsp@novonordisk.com |
Investors: Kasper Roseeuw Poulsen | +45 3079 4303 | krop@novonordisk.com |
Melanie Raouzeos | +45 3075 3479 | mrz@novonordisk.com |
Corporate Communications
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
ZINC ID#: HQMMA/VT/1114/0468
Date of Approval: November 2014
Internet: www.novonordisk.com CVR no:
24 25 67 90
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Daniel Bohsen | +45 3079 6376 | dabo@novonordisk.com |
Frank Daniel Mersebach (US) References | +1 609 235 8567 | fdni@novonordisk.com |
1 Bailey CJ, Day C. Diabetes therapies in renal impairment. B J Diabetes Vas Dis 2012; 12(4):167-
171
2 ClinicalTrials.gov study registration: NCT01620489
3 Davies M, et al. Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes
Medication in Subjects with Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL). Poster
0965-P at 74th Scientific Sessions of the American Diabetes Association (ADA), 15 June 2014.
4 EMA. Victoza® EU Summary of Product Characteristics. Available at:
http://www.medicines.org.uk/emc/medicine/21986/Last accessed 31.10.2014.
5 FDA. Victoza® US prescribing information. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdfLast accessed
31.10.2014.
Novo Nordisk A/SCorporate Communications
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
ZINC ID#: HQMMA/VT/1114/0468
Date of Approval: November 2014
Internet: www.novonordisk.com CVR no:
24 25 67 90
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