FDA approves Novo Nordisk's new weight loss treatment

WASHINGTON - Dec. 30, 2014 - PRLog -- The U.S Food and Drug Administration has greenlighted Novo Nordisk’s new drug application (NDA) for Saxenda®  a once daily once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with a weight-related comorbid condition.

Over  5,000 individuals who were obese or overweight with comorbid conditions participated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program. Clinical data revealed Saxenda® in combination with diet and exercise resulted in a higher weight loss rate as opposed to only diet and exercise alone.  “Many people with obesity suffer from comorbidities. Saxenda® has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve certain risk factors of weight-related comorbidities,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Roughly one- third of the adult population in the United States lives with obesity. Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said: “Obesity often has serious health consequences, but it has long been underdiagnosed and undertreated. We welcome new tools in the fight against obesity and anticipate that it will be a catalyst to further progress in the understanding and treatment of this complex disease.”

Saxenda® is expected to be launched in the United States in the first half of 2015.

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