FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market

Date : 04/19/2012 @ 1:53PM
Source : Dow Jones News
Stock : Amylin Pharmaceuticals, Inc. (MM) (AMLN)
Quote : 30.98  0.0 (0.00%) @ 2:05AM

FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market

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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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