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Novo Nordisk's Victoza Receives FDA Approval for the Treatment of Type 2 Diabetes

Jan 28, 2010

This press release is an announcement submitted by Novo Nordisk, and was not written by Diabetes Health.

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza (liraglutide 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 ordiabetic 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 (1-877-484-2869).

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 anti-diabetic 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.

* * *

Source:

Novo Nordisk press release


Categories: A1c Test, Blood Glucose, Blood Sugar, Diabetes, Diabetes, Food, Insulin, Low Blood Sugar, Medications, Novo Nordisk, Research, Type 1 Issues, Type 2 Issues, Victoza



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Comments

Posted by Anonymous on 28 January 2010

Why do all these 'helpful' drugs has serious side effects? Is the period of testing too short? Or do the reseachers/scientists just want to get the drugs out there quickly for the revenue they can provide? We all remember Vioxx and Thalidomide and a myriad of other drugs supposedly invented to make our quality of life better but which inturn create new problems.
Disenchanted sufferer

Posted by Anonymous on 15 March 2010

I started Victoza injections one week ago. No side effects except headaches so far. It does concern me that its a new drug, but at this point the benefits out weigh the possible future problems.

Posted by Tamela on 31 March 2010

I have only taken two doses of Victoza and the second day I was so nauseous all day and into today. No wonder you can loose weight on this med because you can't eat for all the nausea. It did bring my sugar down but I don't know if it's worth feeling sick to my stomach all the time. And I don't like taking "new" drugs. I would rather take something that's been around for a while.

Posted by Anonymous on 6 May 2010

I treid Victoza, had no problems except my insurance would not approve it as it is a new medication. I have worked on getting my blood sugars down for 10 months and this worked the best, but now I can't get it because insurance says no!


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