September 10th, 2014

FDA Staff: Novo Nordisk Drug Liraglutide Effective for Obesity

FDA Staff: Novo Nordisk Drug Liraglutide Effective for Obesity

September 9, 2014

WASHINGTON - Novo Nordisk's drug liraglutide appears effective in treating obesity, though safety questions remain, according to a preliminary assessment by reviewers at the U.S. Food and Drug Administration.

The report, posted on the agency's website on Tuesday, noted an imbalance in the number of breast malignancies in women who took the drug, but said the available data neither supports nor denies the potential role of the drug in cancer promotion or progression.

The review came two days before a panel of outside advisers is scheduled to meet to decide whether to recommend use of the drug for obesity. The FDA usually follows the advice of its advisors.

Novo Nordisk's shares rose in mid-morning trading on Copenhagen's stock exchange, suggesting investors do not see any major new hurdles to approval.

Liraglutide is already approved to treat Type 2 diabetes, where it is sold under the brand name Victoza. If approved to treat obesity, it could generate an additional $1 billion in revenue, according to analysts.

The company's proposed name for the drug as an obesity treatment is Saxenda. It is known as a GLP-1 analog, which appears to help treat obesity by slowing the speed at which food leaves the stomach.

BATTLING OBESITY

More than one-third of U.S. adults are obese, according to the U.S. Centers for Disease Control and Prevention. Excess weight is a leading cause of heart disease, stroke, type 2 diabetes and certain types of cancers.

Yet treatments remain elusive and have been plagued with safety problems. In 1997, the FDA withdrew fenfluramine and dexfenfluramine, two drugs used in the popular Fen-Phen cocktail after some patients developed heart valve defects.

Phentermine, which was also part of the cocktail, was not withdrawn and has subsequently been re-constituted as part of a weight-loss pill sold, relatively unsuccessfully, by Vivus Inc. The drug, Qsymia, had sales of just $23.7 million in 2013.

Victoza is approved for diabetes at doses of 1.2 mg and 1.8 mg. Novo Nordisk, the world's biggest maker of insulin, is seeking approval to sell the drug at a dose of 3 mg to treat obesity.

In a study known as Scale, half of obese patients given a daily 3 mg injection lost at least 5% of body weight, while 22% lost more than 10%. The drug is proposed for use in patients who also have at least one other weight-related condition, such as hypertension.

Safety questions have dogged Victoza. In March, the FDA denied a request by the consumer watchdog Public Citizen that the agency withdraw Victoza from the market. Public Citizen had argued the drug is associated with an increased risk of thyroid cancer in rats and mice and pancreatitis and that the risks outweigh the benefits.

The agency said in response that those safety concerns were "appropriately and thoroughly considered" at the time of Victoza's initial approval in 2010, and it said no new safety findings have emerged that sufficiently alter the risk-benefit of the drug.

In reviewing the drug for obesity, the FDA focused on rates of pancreatitis, unusual tissue growths, increased heart rates and gastrointestinal problems, as well as gallstones and psychiatric events.

Gallbladder-related problems, which are not identified on the Victoza label, were seen at a higher rate in patients taking liraglutide in the weight-loss trials. The drug is associated with an increase in resting heart rate and has been shown to cause c-cell tumors in rodents.

"The relationship of liraglutide to pancreatitis or pancreatic or thyroid tumors in humans has been speculated, but remains controversial," the reviewer said.

Novo Nordisk's drug, if approved, would compete with Qsymia and Belviq, a drug made by Arena Pharmaceuticals Inc and Eisai that has also had disappointing sales. It may also compete with a new drug from Orexigen Inc. The FDA is due to decide whether to approve Orexigen's product this week.

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