Novo preps for FDA panel hearing on lucrative obesity use for liraglutide

Novo Nordisk ($NVO) has a date with an FDA advisory panel. The subject: Its blockbuster diabetes drug liraglutide, which it's hoping to rebrand into an obesity treatment. What could follow: Big sales from a bigger market.

The Danish drugmaker has been running study after study looking at liraglutide as a weight-loss aid, and filed for FDA approval in December. Just last week, Novo rolled out additional data from a study showing that patients lost 8% of their body weight on 3 mg of liraglutide combined with diet and exercise. For placebo patients, the weight loss amounted to 2.6%.

If the agency panel buys the liraglutide argument--and the FDA follows up with an approval--Novo would waste no time getting the new liraglutide brand on the market. The company has been staffing up in the U.S., partly to ride a wave of recent growth in its modern insulins--and Victoza, the brand name for liraglutide in diabetes. The expanded sales force will also be ready to add the weight-loss aid to its portfolio.

The 3,731 patients in the SCALE study weren't diabetics. Two-thirds did have "prediabetes," marked by a decrease in insulin sensitivity and other problems. All of them were followed on their treatments for 56 weeks. Just 27% of placebo patients lost at least 5% of their body weight, while 64% of liraglutide patients did. One-third of liraglutide users lost more than 10%. And for two-thirds of the prediabetics, liraglutide stamped out signs of diabetes.

The study also raised questions the FDA panel will no doubt want to ask. Some patients in the study developed pancreatitis or gallbladder problems. At last week's American Association of Clinical Endocrinologists, lead author F. Xavier Pi-Sunyer said the gallbladder trouble probably stemmed from weight loss itself, which is known to be linked with gallstones. The overall incidence of either problem was low, the researchers said.

If liraglutide--sold for diabetes as Victoza--can add weight loss to its list of indications, Novo could reap as much as $1 billion in additional annual sales, some analysts say. Others figure the impact will be much, much smaller. The drug would face two relatively new obesity treatments, Vivus' ($VVUS) Qsymia and Arena Pharmaceuticals' ($ARNA) Belviq, in a market that tends to be tough.

Liraglutide has some natural advantages; for one thing, doctors are already familiar with the drug and comfortable with prescribing it. But all weight loss drugs face potential reimbursement hurdles, and doctors can be reluctant to prescribe a drug rather than preach diet and exercise. Plus, liraglutide is an injectable, rather than a pill.

- get the Novo Nordisk release
- read the Clinical Endocrinology News story

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