Jan. 26, 2010 -- The FDA has approved Victoza (liraglutide), a once-daily
injection to treat type 2 diabetes in adults.
Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It isn't
recommended as the first therapy patients try if they haven't adequately
controlled their diabetes with diet and exercise alone.
Victoza belongs to a class of medicines known as glucagon-like peptide-1
(GLP-1) receptor agonists, which 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,” says Mary Parks, MD, director of the
division of metabolism and endocrinology products at the FDA.
“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," Parks says.
The FDA approved Victoza based on
five clinical trials involving more than 3,900 people. In those trials, pancreatitis (inflammation of the pancreas) occurred
more often in patients who took Victoza than in patients taking other diabetes
The FDA states that Victoza should be stopped if patients experience severe
abdominal pain, with or without nausea and vomiting,
and should not be restarted if blood tests confirm that they have pancreatitis.
Victoza should be used with caution in people with a history of pancreatitis,
according to the FDA.
The most common side effects observed with Victoza in the clinical trials
were headache, nausea, and diarrhea. Other side effects included allergic-like
reactions such as hives.
In its clinical trials, Victoza was not linked to an increased risk of
cardiovascular events -- including heart attack, stroke, and death caused by heart disease -- in people who were mainly at low risk
for such events. In keeping with FDA policy, Victoza will be studied further to
check its cardiovascular safety in higher-risk groups.
Other postmarketing studies will evaluate the risk of thyroid cancer and other cancer risks, as well as the
risks of seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic
The FDA notes that in animal studies, Victoza caused tumors of the thyroid
gland in rats and mice. Some of those tumors were cancers, which were more
likely in rats that got doses of Victoza that were eight times higher than what
people would receive.
It's not known if Victoza could cause thyroid tumors or a very rare type of
thyroid cancer called medullary thyroid cancer in people. For that reason, the
FDA says Victoza should not be used as the first treatment for diabetes until
more studies are done.
Victoza should not be used in people who are 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 called multiple endocrine neoplasia
syndrome type 2.
Victoza has a risk evaluation and mitigation strategy to help patients and
health-care providers understand the drug's risks and to ensure that the drug's
benefits outweigh the risk of acute pancreatitis and the potential risk of
medullary thyroid cancer.
Victoza is made by the drug company Novo Nordisk. The launch price of the
1.2-milligram dose will be $8.03 a day.
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