FDA grants approval to Novo Nordisk chronic weight management drug

December 25, 2014

FDA has approved the new drug application (NDA) for liraglutide [rDNA origin] injection (Saxenda, Novo Nordisk) , the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

FDA has approved the new drug application (NDA) for liraglutide [rDNA origin] injection (Saxenda, Novo Nordisk) , the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) in the presence of at least one weight-related comorbid condition.

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“Every time a new obesity treatment drug enters the market there is hope that this may be the one that actually tackles one of the most intractable healthcare issues in the United States and increasingly in the developed world,” said Don Hall,  a former health plan CEO, is principal, Delta Sigma LLC, in Littleton, Colo.  

“While the results for liraglutide [Saxenda] appear marginally better than its competitors, its significantly higher costs and the fact that it is an injectable, make it unlikely to have the market blockbuster impact that Novo desires,” Hall said. “I doubt that it will do much more than fuel the desire for the ‘magic pill’ that consumers want.”

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Saxenda was evaluated in the SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program, which included more than 5,000 study participants who have obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with comorbidities. Trial data showed that Saxenda, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.

In the United States, about one-third of the adult population lives with obesity, leaving them at risk of a myriad of conditions that can affect their overall health. Current guidelines recognize that a sustained weight loss of 5% to 10% provides significant health benefits for adults with obesity.