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FDA Approves Victoza

FDA Approves Novo-Nordisk's Diabetes Drug Victoza

WASHINGTON, Jan. 26, 2010 -- U.S. health officials on Monday approved Danish drugmaker Novo Nordisk's once-daily injection for treating type 2 diabetes but said more safety studies are needed before it can be cleared as a first-line treatment for the disease.

The Food and Drug Administration said it approved the drug, Victoza, to help lower blood sugar levels when coupled with diet, exercise and other diabetes medicines. It was not recommended as an initial therapy for patients who have not been able to control their diabetes with diet and exercise alone.

Novo Nordisk A/S, the world's top producer of insulin, is one of more than a dozen companies developing new therapies to compete in the $5.1 billion U.S. diabetes drug market, which is growing as the disease becomes more prevalent.

Some 23 million Americans have type 2 diabetes, which disrupts the body's ability to break down carbohydrates and control blood sugar.

In April, a panel of government experts were split, voting 6 to 6, on whether the FDA should approve Victoza, also known as liraglutide, in the face of evidence it caused cancerous thyroid tumors in rats and mice.

"It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people," the FDA said. "For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use."

Victoza, belongs to the GLP-1 family of diabetes medications, which also includes Byetta, marketed by Eli Lilly & Co. and Amylin Pharmaceuticals Inc. Both drugs help control blood sugar by increasing insulin production, slowing the body's absorption of sugar.

Novo's drug would enjoy an advantage over Byetta because it requires one injection per day, instead of two.

The company said it expects Victoza, which has been approved in Japan and Europe, to be on the U.S. market within weeks.

U.S.-traded shares of Novo Nordisk rose $1.62, or 2.5 percent, to $67.50 in after-hours dealings after the FDA's announcement late Monday.

Posted: January 2010

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