FDA Approves Novo Nordisk's Victoza for Adults With Type 2 Diabetes

Novo Nordisk (NVO) announced that the US Food and Drug Administration (FDA) approved the new drug application for Victoza (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Victoza was evaluated in The Liraglutide Effect and Action in Diabetes (LEAD) phase III trials, the most comprehensive clinical development program conducted to date by Novo Nordisk in type 2 diabetes. In clinical studies including use as monotherapy and in combination with standard diabetes treatments, Victoza produced significant reductions in A1C and also was associated with weight loss.

"Novo Nordisk is committed to developing safe and effective drugs to treat diabetes, which is why the FDA approval of Victoza represents such an important milestone for the company and for people with type 2 diabetes," says Alan C. Moses, MD, vice president, and chief global medical officer of Novo Nordisk. "Victoza will be a substantial addition to our diabetes portfolio and we believe many people with type 2 diabetes will benefit from this treatment."

"Maintaining control of blood sugar remains a challenge for many type 2 diabetes patients and without control, patients are at risk of developing serious and life-threatening complications," said Alan J. Garber, MD, PhD, FACE, Professor of Medicine, Biochemistry and Molecular Biology, and Cellular Biology Department of Medicine Baylor College of Medicine Houston, Texas. "The approval of Victoza provides patients a once-daily treatment that not only lowers blood sugar, but unlike many other diabetes therapies, does not promote weight gain and is associated with weight loss in the majority of patients. Additionally, it offers patients an attractive new treatment option that has consistently performed well when compared to other currently available treatments."

The American Diabetes Association and European Association for the Study of Diabetes as well as the American Association of Clinical Endocrinologists and the American College of Endocrinology recently updated their treatment algorithms for type 2 diabetes. The algorithms recommend GLP-1 agonists like Victoza as a viable treatment option when blood sugar goals are not met or maintained with lifestyle adjustments and metformin.

Novo Nordisk expects to introduce Victoza in the U.S. market in 4-6 weeks. In addition to the U.S. approval, Victoza has been approved by the European Medicines Agency in all 27 European Union member states, Mexico and Iceland. On January 20th, Victoza was also approved in Japan. A New Drug Application was submitted for China in August 2009, regulatory decision is pending.