Another New Obesity Drug in 2014?

The Danish maker of diabetes drugs, Novo Nordisk, said this week that their new obesity drug, liraglutide, could be ready by the end of 2014. Some business analysts are skeptical about the commercial potential of liraglutide in obesity because of modest efficacy — a view that the company rejects.

In new clinical trial results from 3,731 patients without diabetes, the treatment group lost 8% of their initial weight, significantly more than placebo. A significantly larger proportion of patients (33%) also lost more than 10% of their starting weight versus placebo-treated patients. These results appear to meet FDA criteria for efficacy in obesity treatment.

Liraglutide is currently marketed at a lower dose for treating diabetes under the brand of Victoza. For obesity, the dose studied is 1.7 to 5 times higher than the doses used for treating diabetes.

The view from financial analysts that these results — which meet FDA status — are not good enough for commercial success is a familiar one. Many observers, especially stock analysts, look for weight loss miracles that are not likely to happen any time soon. What obesity doctors need are safe drugs that add to their relatively empty toolbox for treating obesity. And when they come, sustainable successes will not grow explosively, but gradually as doctors carefully incorporate them into the medical management of this difficult chronic disease.

The biggest challenge for liraglutide will be safety, not efficacy. Already at the lower doses used in diabetes treatment, FDA is raising questions about pancreatic safety issues related to liraglutide and other drugs in its class. The higher dose will certainly bring greater scrutiny.

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Nordisk, photograph © pollas / flickr

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