Novo Nordisk's Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes

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Jan 25, 2010, 10:37 ET

PRINCETON, N.J., Jan. 25 /PRNewswire/ -- Novo Nordisk (NYSE: NVO), a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Victoza was evaluated in The Liraglutide Effect and Action in Diabetes (LEAD) phase III trials, the most comprehensive clinical development program conducted to date by Novo Nordisk in type 2 diabetes. In clinical studies including use as monotherapy and in combination with standard diabetes treatments, Victoza produced significant reductions in A1C and also was associated with weight loss.

"Novo Nordisk is committed to developing safe and effective drugs to treat diabetes, which is why the FDA approval of Victoza represents such an important milestone for the company and for people with type 2 diabetes," says Alan C. Moses, M.D., vice president, and chief global medical officer of Novo Nordisk. "Victoza will be a substantial addition to our diabetes portfolio and we believe many people with type 2 diabetes will benefit from this treatment."

"Maintaining control of blood sugar remains a challenge for many type 2 diabetes patients and without control, patients are at risk of developing serious and life-threatening complications, " said Alan J. Garber, MD, PhD, FACE, Professor of Medicine, Biochemistry and Molecular Biology, and Cellular Biology Department of Medicine Baylor College of Medicine Houston, Texas. "The approval of Victoza provides patients a once daily treatment that not only lowers blood sugar, but unlike many other diabetes therapies, does not promote weight gain and is associated with weight loss in the majority of patients. Additionally, it offers patients an attractive new treatment option that has consistently performed well when compared to other currently available treatments."

The American Diabetes Association and European Association for the Study of Diabetes as well as the American Association of Clinical Endocrinologists and the American College of Endocrinology recently updated their treatment algorithms for type 2 diabetes. The algorithms recommend GLP-1 agonists like Victoza as a viable treatment option when blood sugar goals are not met or maintained with lifestyle adjustments and metformin.

Novo Nordisk expects to introduce Victoza in the U.S. market in 4 – 6 weeks. In addition to the U.S. approval, Victoza has been approved by the European Medicines Agency (EMEA) in all 27 European Union member states, Mexico and Iceland. On January 20th, Victoza was also approved in Japan. A New Drug Application was submitted for China in August 2009, regulatory decision is pending.

Indications and Usage

Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. It has not been studied sufficiently in patients with a history of pancreatitis. Victoza should not be used to treat type 1 diabetes mellitus or diabetic ketoacidosis. It has not been studied in combination with insulin.

About Victoza

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

In clinical studies submitted for FDA review, Victoza's® safety and efficacy were evaluated in five trials, one of 52-weeks duration and four of 26-weeks duration. These multinational trials evaluated Victoza in monotherapy as well as in combination with one or two oral anti-diabetic medications and showed better lowering of blood glucose than active comparators such as sulfonylureas and thiazolidinediones. A1C reductions for Victoza 1.8 mg, in combination or as monotherapy, ranged from 1.0% to 1.5% across the five clinical studies with baselines ranging from 8.2% to 8.6%. Victoza 1.8 mg + metformin reduced A1C by 1.0% and reduced weight by 6.2lbs. The most common adverse reactions reported in patients treated with Victoza are headache, nausea, diarrhea, and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza-treated patients than among comparator-treated patients in clinical trials.

For full prescribing information, please go to Victoza.com or call 1-877-4VICTOZA (484-2869).

Conference call

On January 26, 2010 at 08:00 am CET, corresponding to 02:00 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com. Presentation material for the conference call will be made available approximately one hour before on the same page, and a replay of the conference call will be available approximately two hours after its conclusion.

Important Safety Information

Victoza causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

In clinical trials, there were more cases of pancreatitis among Victoza-treated patients than among comparator-treated patients. If pancreatitis is suspected, Victoza should be discontinued. Victoza should not be re-initiated if pancreatitis is confirmed. Use with caution in patients with a history of pancreatitis.

When Victoza is used with an insulin secretagogue (e.g. a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza or any other antidiabetic drug.

The most common adverse reactions reported in patients treated with Victoza are headache, nausea, diarrhea, and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza-treated patients than among comparator-treated patients in clinical trials.

Victoza has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

Victoza should be used with caution in patients with renal impairment and in patients with hepatic impairment.

About Type 2 Diabetes

Approximately 220 million people worldwide have diabetes, the vast majority of which is type 2 which is caused by a combination of insulin resistance and inadequate and progressive dysfunction of the cells (beta cells) that produce and release insulin. In fact, studies show that 50% of beta-cell function is lost by the time of diagnosis. In the U.S. alone, approximately 24 million people have type 2 diabetes. Despite the availability of many treatments, close to 45% of people with type 2 diabetes are not achieving A1C goals. Lack of glycemic control puts patients at serious risk; for every 1% increase in A1C above 6%, the risk of death increases by 20%.

Further complicating the disease, 85% of people with type 2 diabetes are overweight or obese, and obesity increases insulin resistance, cardiovascular risk, and mortality. People with type 2 diabetes are at high risk of cardiovascular disease and have higher morbidity and mortality when cardiovascular events occur.

As the burden of type 2 diabetes continues to grow, innovation in developing drugs and improving health care delivery is needed if the epidemic and its consequences are expected to be stopped or reversed.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 29,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.

SOURCE Novo Nordisk