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Lilly, Boehringer Win FDA Approval for Type 2 Diabetes Drug

Eli Lilly & Co. and Boehringer Ingelheim GmbH won U.S. approval of a new drug to improve blood glucose control in people with Type 2 diabetes.

The drug, linagliptin, was shown to be safe and effective in eight clinical studies involving about 3,800 patients with Type 2 diabetes, the most common form of the disease, the Food and Drug Administration said today in a statement.

Linagliptin, to be sold under the name Tradjenta, is among four diabetes treatments Indianapolis-based Lilly and Ingelheim, Germany-based Boehringer agreed in January to develop and sell jointly. The companies said they will equally divide the development and marketing costs and gross margin.

“This approval provides another treatment option for the millions of Americans with Type 2 diabetes,” Mary Parks, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the statement. “It is effective when used alone or when added to existing treatment regimens.”

Lilly gained 30 cents, or less than 1 percent, to $37.31 at 4 p.m. in New York Stock Exchange composite trading.

Almost 26 million people in the U.S have diabetes, and 90 to 95 percent have the Type 2 version, according to the Centers for Disease Control and Prevention. People who are obese are among those most at risk for developing the disease, which prevents the body from using insulin properly to control blood glucose levels. Type 2 diabetes, left untreated, can lead to heart attack, stroke and blindness.

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