Danish insulin giant Novo Nordisk has decided to re-initiate the global Phase III development program of its diabetes drug of liraglutide for the treatment of obesity.
Following the US approval of Victoza (liraglutide) for the treatment of type 2 diabetes earlier this year (The Pharma Letter January 26), Novo Nordisk has been in dialogue with the US Food and Drug Administration regarding the further progression of the development program investigating the potential of the compound within obesity. Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global Phase III program in the first half of 2011 in clinical trials comprising approximately 5,000 patients.
The re-initiation of liraglutide obesity trials underlines Novo Nordisk's dedication to the development of the liraglutide portfolio, that is the cardiovascular outcomes trial for Victoza (LEADER), the obesity program, the fixed-ratio combination of insulin degludec and liraglutide, and finally a once-weekly version of liraglutide.
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