Tresiba® and Victoza® receive positive opinions from CHMP for label updates expanding indications for use in adults with type 2 diabetes

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Copenhagen, Denmark, 21 March 2014 - The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of Tresiba® (insulin degludec) and Victoza® (liraglutide) in type 2 diabetes. Once the European Commission approves the label expansion, physicians will be able to prescribe Tresiba®, the once-daily, long-acting basal insulin in combination with GLP-1 receptor agonists, such as Victoza®. Similarly, Victoza®, the once-daily human glucagon-like peptide-1 (GLP-1 analogue), can be prescribed in combination with a basal insulin.

Tresiba® was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti-diabetic (OAD) medicinal products or with mealtime insulin1. Victoza® was approved in Europe in 2009 for the treatment of type 2 diabetes in adults in combination with OADs2.

"This is excellent news for patients with type 2 diabetes and their physicians. The update expands the options physicians have to individualise therapy for their patients and help them achieve glycaemic targets, especially if they have concerns about hypoglycaemia and weight gain," said Professor Chantal Mathieu, Katholieke Universiteit Leuven, Belgium, the lead study investigator of the BEGIN: VICTOZA® ADD-ON trial.

The CHMP recommendation for both Tresiba® and Victoza® was based on efficacy and tolerability data from four phase 3 clinical trials3-6. All four trials were conducted in adults with type 2 diabetes.

About the studies

Pivotal data came from the BEGIN: VICTOZA® ADD-ON3 26-week open-label extension to a 104-week clinical trial in which 57% of patients treated with Tresiba® in combination with metformin achieved a target HbA1c <7%. Patients who did not achieve the HbA1c target were randomised to receive either a single dose of NovoRapid® (insulin aspart), with the largest meal or once-dailyVictoza® in addition to Tresiba® and metformin for 26 weeks.

Study results include:

The addition of Victoza® once-dailyversus a single dose of NovoRapid® showed statistically significantly greater reduction of HbA1c (-0.73% versus -0.40%*) and body weight (-3.03 kg versus +0.72 kg)3.

The observed rate of confirmed hypoglycaemic episodes (per patient year of exposure) was significantly lower when adding Victoza® once-dailycompared to a single dose of NovoRapid® (1.0 versus 8.15; estimated rate ratio: 0.13; 95% CI 0.08 to 0.21; p<0.0001)3.

The three supportive studies included in the CHMP review were:

DUAL™ I, which compared the efficacy and safety of IDegLira (a combination of insulin degludec and liraglutide in one pen) versus Tresiba® or Victoza® alone in patients with type 2 diabetes, which was uncontrolled on metformin ± pioglitazone4.

DUAL™ II, which compared the efficacy and safety of IDegLira versus Tresiba® alone in people with type 2 diabetes, which was uncontrolled on basal insulin (20-40U) + metformin ± sulfonylurea or glinides5.

LIRA-DETEMIR™, which compared a combination of the basal insulin Levemir® (insulin detemir) and Victoza® versus Victoza® alone in insulin-naïve patients with type 2 diabetes on metformin6.

About Tresiba®

Tresiba® (insulin degludec) is the global brand name for insulin degludec, a basal insulin discovered and developed by Novo Nordisk. Once-daily Tresiba® provides a long duration of action beyond 42 hours, allowing for flexibility in day-to-day dosing time when needed with a minimum of eight hours and a maximum of 40 hours between injections, without compromising efficacy or risk of hypoglycaemia. Tresiba® has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and flexibility in day-to-day dosing time when needed. Tresiba® has received regulatory approval in Argentina, Aruba, Bangladesh, Brazil, Chile, El Salvador, the EU, Iceland, India, Japan, Lebanon, Lichtenstein, Macedonia, Mexico, Norway, Russia and Switzerland.

About Victoza®

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® was launched in the EU in 2009 and is commercially available in more than 65 countries globally. Currently, there are more than 790,000 patients receiving Victoza® worldwide7. In the US, Victoza® was approved on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Hypoglycaemia has primarily been observed when Victoza® is combined with a sulfonylurea.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 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 38,000 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

Rachel Cummings (UK)

+44 7725 289520

racu@novonordisk.com

Investors:

   

Kasper Roseeuw Poulsen

+45 3079 4303

krop@novonordisk.com

Frank Daniel Mersebach

Daniel Bohsen

+45 3079 0604

+45 3079 6376

fdni@novonordisk.com

dabo@novonordisk.com

Lars Borup Jacobsen

+45 3075 3479

lbpj@novonordisk.com

Jannick Lindegaard (US)

+1 609 235 8567

jlis@novonordisk.com

 

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References:

Tresiba® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2013.

Victoza® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2009.

Mathieu C, et al. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type?2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jan 20 [epub ahead of print].

DUAL™ I. Data on file NN9068-3697.

DUAL™ II. Data on file NN9068-3912.

DeVries JH, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012;35:1446–54.

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