FDA approved Novo Nordisk’s injection for obesity

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On Dec. 23, 2014, the U.S. Food and Drug Administration (FDA) approved a formulation of Novo Nordisk’s diabetes drug, liraglutide, for treating patients of obesity, a disease that affects one in three Americans. 

The injectable drug, to be marketed as Saxenda, is the second obesity treatment to be approved this year after Orexigen Therapeutics’s oral medication Contrave in September. Saxenda enters a market that is yet to realize its potential due to limited effectiveness of existing drugs, reimbursement hurdles, bungled launches and the perception of obesity as a ‘lifestyle’ disease. 

The drug has been approved for patients with a body mass index of 30 or above and at least one weight-related health condition such as diabetes, the FDA said. A lower dose of liraglutide, marketed as Victoza, was approved for use in diabetes patients in 2010. Novo believes Saxenda has blockbuster potential, although doctors doubt it will be a game changer.

A study showed that half the patients given Saxenda lost at least 5 percent body weight, the FDA said. Rival drugs show 2-5 percent weight loss over and above diet and exercise. Saxenda, which works by slowing the speed at which food leaves the stomach, has a better chance of being covered under Medicare and Medicaid than rival drugs due to Victoza’s established safety profile.

The FDA has pulled obesity drugs off the shelves in the past, after a series of lawsuits sought to link them with debilitating side effects. As a result, doctors are reluctant to prescribe drugs without an established record of their efficacy.

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Source: Reuters
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