[acb-diabetics] from Diabetic Health magazine

[Patricia LaFrance-Wolf]

>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 (1-877-484-2869).

 

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

 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://www.acb.org/pipermail/acb-diabetics/attachments/20100129/60e0d534/attachment-0001.htm>