FDA approves Novo Nordisk's Victoza for Type 2 diabetes

ROCKVILLE, Md. The Food and Drug Administration has approved a long-awaited treatment for Type 2 diabetes, the agency announced Monday.

The FDA approved Novo Nordisk’s Victoza (liraglutide), a once-daily injection for adults. The drug belongs to the class known as glucagon-like peptide-1 receptor agonists, which also includes Eli Lilly & Co.’s and Amylin’s Byetta (exenatide).

“Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually,” FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products director Mary Parks said in a statement. “Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with Type 2 diabetes a treatment option for controlling their blood glucose levels.”

Novo Nordisk heralded the news, saying it would introduce Victoza into U.S. markets “within weeks.”

“The U.S. approval of Victoza represents a major advancement in the treatment of Type 2 diabetes and is an important milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe,” Novo Nordisk president and CEO Lars Rebien Sorensen said. "We are convinced that Victoza will prove to be a valuable treatment option for people with Type 2 diabetes in the U.S. The ability of Victoza to substantially improve glucose control with a low risk of hypoglycemia creates an opportunity for more patients with Type 2 diabetes to achieve their individual treatment goals.”

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