Danish insulin giant Novo Nordisk (NOVN: N) has released headline results from a 56-week, double-blind Phase IIIa clinical trial investigating the potential of liraglutide (trade name Victoza) to induce and maintain weight loss in overweight or obese people with type 2 diabetes.
This is the second Phase IIIa trial to be completed as part of SCALETM, the clinical development program for liraglutide 3mg as an obesity treatment. Liraglutide is currently approved and marketed at lower doses (1.2mg and 1.8mg once-daily as well as 0.9 mg in Japan) for type 2 diabetes only. Victoza, which generated sales of 9.5 billion Danish kroner ($1.66 billion) in 2012, is not approved for weight management and should not be prescribed for its treatment, the company noted.
Should liraglutide gain approval for a weight-loss indication this could provide a lucrative niche market use, but some in the industry are skeptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity. Novo Nordisk believes the approach can offer cost-effective benefits. However, the recent announcement that the US Food and Drug Administration is investigating the use of GLP-1 drugs and a possible higher risk of pancreatitis could make the regulatory pathway quite difficult.
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