from Diabetic Health magazine

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From Diabetic Health magazine

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-).

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