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Victoza Label Updated

Victoza Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia

Princeton, N.J. (April 9, 2012) /PRNewswire/ - Novo Nordisk received approval from the U.S. Food and Drug Administration (FDA) to update the product label for Victoza (liraglutide [rDNA origin] injection) to include data showing superior blood sugar control when compared to Januvia (sitagliptin). Victoza also provided greater weight reduction. Both products were taken in combination with metformin in adults with type 2 diabetes.

The update also includes data demonstrating the safety and efficacy of adding basal insulin to Victoza and metformin for the treatment of adults with type 2 diabetes.

“We’re pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia, said Camille Lee, Corporate Vice President, Diabetes Marketing at Novo Nordisk. “The additional data supporting combination therapy with basal insulin further demonstrates that Victoza is an appropriate option for a wide variety of adults with type 2 diabetes.”

The label update was based on the FDA’s review of two large, randomized, open-label studies in adults with type 2 diabetes. Key findings from the studies include:

Victoza vs. Januvia

Patients treated with 1.2 mg and 1.8 mg of Victoza experienced greater reductions in A1C than those treated with Januvia 100 mg tablets, all in combination with metformin (-1.2% and -1.5% vs. -0.9%).

Victoza provided greater weight loss versus patients treated with Januvia (2.7 kg [5.94 lbs] and 3.3 kg [7.26 lbs] for 1.2 mg and 1.8 mg respectively, 0.8 kg [1.76 lbs] for Januvia).

Victoza is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.
•In the 26-week, open label study (n=665), the adverse reactions reported in ≥5% of the patients treated with Victoza and ≥5% of patients treated with Januvia were nausea (23.9% vs. 4.6%), headache (10.3% vs. 10.0%), diarrhea (9.3% vs. 4.6%) and vomiting (8.7% vs. 4.1%).

Adding Levemir (insulin detemir [rDNA origin] injection) to Victoza and metformin in adults with type 2 diabetes

After completing 12 weeks of treatment with Victoza and metformin, 50% of patients reached the ADA target for blood sugar control (A1C <7%).

After an additional 26 weeks, patients randomized to add on Levemir once a day to their Victoza and metformin regimen had further A1C reductions of -0.5%.

Furthermore, 43% of patients in the Victoza, metformin and Levemir group reached the ADA target for blood sugar control (A1C <7%) at 26 weeks versus an additional 17% in the Victoza and metformin group.

Patients did not gain weight after Levemir was added.

In the 26-week study (n=323) of Victoza 1.8 mg and intensification with Levemir, the only adverse reaction reported in ≥5% of the patients treated with Victoza 1.8 mg + metformin + insulin detemir and ≥5% in patients treated with Victoza 1.8 mg + metformin alone was diarrhea (11.7% vs. 6.9%, respectively).

“Patients continue to struggle with the management of their blood sugar throughout the progression of their diabetes,” said Richard E. Pratley, M.D., Director, Florida Hospital Diabetes Institute. “Having Victoza as an add-on therapy to metformin early in the treatment paradigm as well as later, in combination with other oral agents and basal insulin, is important.”

About Victoza (liraglutide [rDNA origin] injection)

Victoza, is the first and only human glucagon-like peptide-1 (GLP-1) analog that is 97 percent similar to endogenous human GLP-1. Like natural GLP-1, Victoza works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.

Victoza was approved by the U.S. Food and Drug Administration (FDA) on January 25, 2010, as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

As of October 2011, Victoza has been commercially launched in more than 40 countries globally including the U.S., Canada, Japan, UK, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, the GULF, Malaysia and China as well as a number of other countries, and will be available in other markets throughout 2012.


Victoza is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.

Victoza is not recommended as the first medication to treat diabetes. Victoza is not a substitute for insulin and has not been studied in combination with prandial (meal-time) insulin. Victoza is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza is safe and effective in children. Victoza is not recommended for use in children.

Important Safety Information
In animal studies, Victoza caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early. Do not use Victoza if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

While taking Victoza, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Do not use Victoza if you are allergic to liraglutide or any of the ingredients in Victoza. Serious allergic reactions can happen with Victoza. If symptoms of serious allergic reactions occur, stop taking Victoza and seek medical attention.

Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Before taking Victoza, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis.

Stop taking Victoza and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.

Before using Victoza, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza may affect how each medicine works. If you use Victoza with insulin, you may give both injections in the same body area (for example, your stomach area), but not right next to each other.

Also tell your doctor if you have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; or are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza will harm your unborn baby or if Victoza passes into your breast milk.

Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking Victoza.

Victoza may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.

The most common side effects with Victoza include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza compared to people treated with other diabetes drugs in medical studies.

Please see www.victoza.com for Victoza complete Prescribing Information.

About Novo Nordisk

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk-us.com.

About Type 2 Diabetes

In the United States alone, nearly 26 million people are affected by diabetes. Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases. Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has tripled over the last 30 years.

For further information please contact:

Media:
Investors:

In North America:


Havilah Clarke
Jannick Lindegaard

Tel: (+1) 609 423 3057
Tel: (+1) 609 786 4575

hvck@novonordisk.com
jlis@novonordisk.com
Ambre Morley
Tel: (+1) 609 987 5898
abmo@novonordisk.com

In Europe:
Katrine Sperling
Klaus Bülow Davidsen

Tel: (+45) 4442 6718
Tel: (+45) 4442 3176

krsp@novonordisk.com
klda@novonordisk.com
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com


Victoza and Levemir are registered trademarks of Novo Nordisk A/S. Januvia is a registered trademark of Merck & Co.

Posted: April 2012

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