Eli Lilly and Co. and FDA and Health Care Businesses and Health Care & Life Sciences and Health Care & Insurance and Pharmaceutical

Lilly diabetes drug wins approval for expanded use

October 19, 2011

Eli Lilly and Co. and Amylin Pharmaceuticals Inc.’s Byetta has received expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.

The Food and Drug Administration cleared the injectable medicine, first approved in April 2005, to be used by patients taking insulin glargine, a long-acting insulin marketed by French drugmaker Sanofi as Lantus, Amylin and Lilly said Wednesday in a prepared statement.

The move would “make Byetta available to millions of insulin-using Type 2 diabetes patients in the United States,” Vincent Mihalik, senior vice president of sales and marketing at Amylin, said in an April earnings call.

Almost 26 million people ages 20 or older in the U.S. have diabetes, according to the American Diabetes Association in Alexandria, Va. At least 90 percent of those have Type 2, the most common form of the disease in which the body doesn’t produce enough insulin or the cells ignore the insulin. Most Type 2 patients need at least one insulin shot daily.

“This expanded use for Byetta is important for clinical care, in that it provides a new option for the many patients with Type 2 diabetes who are not achieving treatment goals,” John Buse, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill, said in the statement released by the companies.

Byetta stimulates the pancreas cells to produce insulin when blood sugar is high. It has been approved for patients taking other diabetes medicines and on its own as a therapy with diet and exercise.

The drug brought in $559 million for San Diego-based Amylin last year, almost 85 percent of the company’s revenue, according to data compiled by Bloomberg. The drug accounted for $151 million in sales for Indianapolis-based Lilly last year.

Sanofi said last week it expects Lantus to generate 2011 sales of $5.48 billion.

Amylin sued Lilly in federal court alleging anticompetitive activity and breach of a strategic alliance agreement, the company said in a statement in May. Amylin wants to stop Lilly from using the same sales force to promote linagliptin, a product Lilly is developing with German drugmaker Boehringer Ingelheim GmbH to complete with Byetta and a once-weekly version called Bydureon under review by the FDA.

Linagliptin, sold under the name Tradjenta, was approved in May by the FDA for sale in the U.S.


 

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