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Novo Nordisk's Drug for Obesity Treatment Gets FDA Panel Approval

Sep 12, 2014 09:48 AM EDT
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U.S. Food and Drug Administration advisers have backed Novo Nordisk's drug liraglutide for obesity treatment.

The drug was voted 14-1 by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of FDA. The panel said that the benefits of the injectable drug outweigh its harms and that the federal agency might consider approving liraglutide for the treatment of obesity.

Liraglutide is now available as a daily injection for type-2 diabetes. The drug belongs to a class of medication called GLP-1 agonists, which coax the pancreas to secrete more insulin after meals, The Associated Press reported. The drug is sold under the brand name Victoza.

FDA usually follows the recommendation of the advisors. Novo Nordisk's shares grew 1.8 percent to $46.78 on the New York Stock Exchange just before the vote, Reuters reported.

Dr. David Kelsen of the Memorial Sloan Kettering Cancer Center was the only person on the panel to oppose the drug. He said that the current research backing the drug doesn't satisfactorily demonstrate that it wouldn't increase cancer risk. "Until that information is available, there is a risk of uncertainty," he told Reuters.

The Danish drugmaker Novo Nordisk intends to call the new obesity treatment drug Saxenda.

"We are pleased with the clear recommendation from the Advisory Committee," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, according to a news release. "We look forward to working with the FDA as they complete their review of Saxenda®. Obesity is a serious public health issue in the United States and we are committed to making Saxenda® a new treatment option for adults with obesity."

The safety and efficacy of the drug was established via clinical trials conducted on over 5,000 people who were either obese, with a body mass index of 30 or more or were overweight, with BMI of 27 plus a chronic condition such as diabetes.

If approved, Novo Nordisk's injectable drug is expected to cost about $25 a day.

Recently, FDA approved Orexigen Therapeutics Inc., weight-loss pill Contrave

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