Diabetes in Spain

Novo Nordisk’s Victoza® Receives FDA Approval for Adults With Type 2 Diabetes

Posted on 26. Jan, 2010 by Mike in Diabetes News

Novo Nordisk announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza®, the first once-daily human glucagon-like injection for the treatment of type 2 diabetes. Victoza is indicated as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Some Victoza® (liraglutide) facts:

Is a once-daily human analogue injection approved for the treatment of type 2 diabetes in adults.

Has 97% similar to the body’s own hormone (GLP-1). GLP-1 is a natural hormone in the body that plays a critical role in maintaining a healthy level of sugar in the blood. In type 2 diabetes, GLP-1 production and function is often impaired.

New Victoza Pen

Lowers blood sugar levels by stimulating the release of insulin from beta cells and reducing the release of glucagon from alpha cells when blood sugar levels are high and by slowing gastric emptying.

Insulin lowers blood sugar by increasing sugar uptake primarily in muscles, liver and fat.

Glucagon increases blood sugar primarily by releasing sugar stores in the liver.

Also, reduces body weight and body fat mass in people with type 2 diabetes through mechanisms involving reduced hunger and lowered energy intake.

Is a once-daily injection given any time of day independent of meals.

Was extensively tested in a clinical trial programme including more than 6,500 people.

Has been directly compared, in terms of safety and efficacy, against commonly-used diabetes treatments like glimepiride, rosiglitazone, glargine, exenatide and sitagliptin in phase 3a and b clinical trials. 3-9

Has been documented in clinical trials to;

• Reduce blood sugar levels
• Reduce weight
• Reduce blood pressure
• Improve the function of insulin-producing beta cells

Note: Victoza® is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with:

• Metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea.
• Metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

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2. Victoza Type 2 Diabetes Injection Approved By EU
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4. Researchers to implant pig cells in diabetics

Tags: adults, approval, diabetes, fda, liraglutide, novo nordisk, type 2, usa, victoza