FDA Approves NDA for Novo Nordisk’s Weight Loss Injectable Saxenda

FDA Approves NDA for Novo Nordisk’s Weight Loss Injectable Saxenda

Novo-NordiskDanish multinational pharmaceutical company, Novo Nordisk, has just announced that the US Food and Drug Administration has endorsed the company’s new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist formulated for long-term weight control. The weight loss therapy is recommended as an adjunct treatment to a reduced and balanced diet and an exercise regimen in adults who are clinically obese or overweight, with at least 1 weight-related comorbidity or illness.

The United States faces an obesity epidemic, as the Centers for Disease Control and Prevention estimate 1 out of every 3 Americans to be obese. Being overweight and obese is known to increase the risk of developing a myriad of serious and chronic diseases, and is considered one of the chief factors in discouraging disease outcomes, whether it is diabetes or cancer. Current guidelines suggest a sustained weight loss of 5%-10% can result in notable health benefits in obese adults.

Saxenda® was assessed using the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) Phase III clinical trial. The researchers treated over 5,000 obese and overweight patients diagnosed with comorbidities, and found that the drug, together with dieting and exercise, helped patients achieve bigger weight loss compared to dieting and exercise alone.

Mads Krogsgaard Thomsen, the executive vice president and chief science officer of Novo Nordisk, said a great number of obese patients have comorbidities that could benefit significantly from an effective weight loss regimen and pharmacological assistance.

“Obesity has many root causes and there is a clear need for additional treatment options to help health care professionals better address our patients’ individual conditions and goals for weight management,” said Dr. Donna Ryan, professor and associate executive director of clinical research at the Pennington Biomedical Research Center. “The approval of Saxenda® provides us with a new therapeutic approach for helping our patients achieve and maintain a healthier body weight.”

The President and Chief Executive Officer of Obesity Action Coalition, Joe Nadglowski, said that while obesity has more often than not directly caused or made difficult a number of serious illnesses, it has not received enough attention and urgency from the field of biomedical research and healthcare. He believes it is high time for newer, more reliable tools and treatments to enter the market, for the prevention of life-altering and life-threatening consequences of obesity.

Novo Nordisk predicts Saxenda® to make its US debut in the first half of 2015.

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