Victoza (liraglutide) Gets FDA Approval as New
Treatment for Type 2 Diabetes
Seniors aged 60 with type 2 diabetes are about
one-third of all adults with this chronic disease
Jan. 27, 2010 - Victoza (liraglutide), a drug
intended to help lower blood sugar levels along with diet, exercise, and
selected other diabetes medicines, was approved on January 25 for a
once-daily injection to treat type 2 diabetes in some adults.. It is not
recommended as initial therapy in patients who have not achieved
adequate diabetes control on diet and exercise alone, according to the
Food and Drug Administration.
Study of seniors finds physical activity, good
dietary habits, not smoking and light alcohol use lowers diabetes risk
by 82%; four in five new cases attributable to not having these low-risk
factors.
Insulin is a hormone that helps prevent sugar
(glucose) from building up in the blood. People with type 2 diabetes
have difficulty making and using insulin. Victoza is in a class of
medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists
that help the pancreas make more insulin after eating a meal.
"Diabetes is a leading cause of death and
disability, with more than 1.5 million new cases diagnosed annually,"
said Mary Parks, M.D., director, Division of Metabolism and
Endocrinology Products in the FDA’s Center for Drug Evaluation and
Research.
"Controlling blood sugar levels is very important
to preventing or reducing the long term complications of diabetes, and
Victoza offers certain patients with type 2 diabetes a treatment option
for controlling their blood glucose levels."
In five clinical trials involving more than 3,900
people, pancreatitis (inflammation of the pancreas) occurred more often
in patients who took Victoza than in patients taking other diabetes
medicines.
Victoza should be stopped if there is severe abdominal pain,
with or without nausea and vomiting, and should not be restarted if
pancreatitis is confirmed by blood tests. Victoza should be used with
caution in people with a history of pancreatitis.
The most common side effects observed with Victoza
were headache, nausea, and diarrhea. Other side effects included
allergic-like reactions such as hives.
Victoza was not associated with an increased risk
for cardiovascular events in people who were mainly at low risk for
these events.
FDA approved Victoza, however, with several post-marketing
requirements under the Food and Drug Administration Amendments Act (FDAAA)
to ensure that the company will conduct studies to provide additional
information on the safety of this product.
In addition to a cardiovascular safety study to
specifically evaluate the cardiovascular safety of Victoza in a higher
risk population, the company also is required to conduct a 5-year
epidemiological study using a health claims database to evaluate thyroid
and other cancer risks as well as risks for seriously low blood glucose
levels (hypoglycemia), pancreatitis, and allergic reactions.
To specifically evaluate the risk of medullary
thyroid cancer, the company is required to establish a cancer registry
to monitor the rate of this type of cancer in the United States over the
next 15 years.
In animal studies, Victoza caused tumors of the
thyroid gland in rats and mice. Some of these tumors were cancers, which
were significantly increased in rats who received excessive doses that
were 8-times higher than what humans would receive.
It is not known if Victoza could cause thyroid
tumors or a very rare type of thyroid cancer called medullary thyroid
cancer in people. For this reason, Victoza should not be used as the
first-line treatment for diabetes until additional studies are completed
that support expanded use.
Also, Victoza should not be used in people already
at risk for medullary thyroid cancer, such as those who have medullary
thyroid cancer in the family or those with a rare genetic condition
known as Multiple Endocrine Neoplasia syndrome type 2.
To ensure the safe and effective use of this
product, Victoza was approved with a Risk Evaluation and Mitigation
Strategy consisting of a Medication Guide and a Communication Plan to
help patients and providers understand the risks of Victoza and to
ensure that the benefits of the drug outweigh the risk of acute
pancreatitis and the potential risk of medullary thyroid cancer.
Victoza is manufactured by Novo Nordisk of
Bagsvaerd, Denmark.
Novo Nordisk
expects to introduce Victoza in the US market within weeks.
Jan. 27, 2010 - Victoza (liraglutide), a drug
intended to help lower blood sugar levels along with diet, exercise, and
selected other diabetes medicines, was approved on January 25 for a
once-daily injection to treat type 2 diabetes in some adults.. It is not
recommended as initial therapy in patients who have not achieved
adequate diabetes control on diet and exercise alone, according to the
Food and Drug Administration.
The most common side effects observed with Victoza
were headache, nausea, and diarrhea. Other side effects included
allergic-like reactions such as hives.