FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market
April 19 2012 - 1:53PM
Dow Jones News
A consumer advocacy group is asking the U.S. Food and Drug
Administration to remove Novo Nordisk's (NVO, NOVO-B.KO) diabetes
drug Victoza from the market because of safety concerns.
In a petition filed Thursday by Washington-based Public Citizen,
the group said Victoza puts patients at higher risk of thyroid
cancer, pancreatitis and kidney failure, outweighing any benefits
from the drug.
The FDA doesn't comment on petitions pending before the agency,
and typically takes months or years to respond to such petitions.
Novo Nordisk didn't immediately respond to a request for
comment.
Victoza was approved by the FDA in 2010. The product's sales
have steadily increased and reached so-called blockbuster status
with $1.1 billion in sales last year.
At the time of approval, FDA said it believed Victoza's benefits
at treating type-2 diabetes outweighed potential risks, including
pancreatitis, which is an inflammation of the pancreas that in rare
cases can be fatal, and a type of thyroid cancer.
Cases of a rare type of thyroid cancer were seen in animal
studies of Victoza, but FDA said in 2010 that "the relevance of
this finding in humans is unknown."
Novo Nordisk is required to conduct a five-year postmarketing
study of Victoza to evaluate safety issues and to set up a registry
for medullary thyroid cancer.
Dr. Sidney Wolfe, the director of Public Citizen's health
research group, said a review of FDA's adverse events database
showed 200 reports of acute pancreatitis associated with Victoza
during a 17-month period that ended in September, and 26 reports of
thyroid tumors among patients taking liraglutide.
FDA adverse-event reports don't necessarily mean a product has
caused a particular problem, but they are used by the agency and
other researchers to track potential safety problems.
Victoza is a long-acting form of a hormone known as GLP-1 that
triggers the release of insulin in the body, which is needed to
properly digest and use sugar from food. It falls into a class of
drugs known as GLP-1 receptor agonists and is similar to Byetta,
and its long-acting version Bydureon, both by Amylin
Pharmaceuticals Inc. (AMLN). All of the drug labels currently warn
about the risk of pancreatitis while the labels for Victoza and
Bydureon discuss thyroid tumors found in rat studies.
The class of drugs is recommended only after treatment with
other diabetes drugs, such as metformin, fails to lower blood
sugar.
About 26 million Americans have type-2 diabetes, a disease
characterized by high blood-glucose levels that result from the
body's inability to produce or use insulin. Type-2 diabetes is
linked with obesity, poor diet and lack of exercise. Diabetes also
increases the risk of heart attacks and strokes, as well as kidney
and other health problems.
Novo Nordisk ADRs were down nine cents in recent trading, at
$150.68.
-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294;
jennifer.corbett@dowjones.com
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