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Lilly receives Europe's OK for new Byetta use

March 23, 2012

European regulators have approved an expanded use for the diabetes treatment Byetta developed by drugmakers Amylin Pharmaceuticals Inc. and Eli Lilly and Co.

The companies said Friday they received approval for Byetta to be used with or without common treatments like metformin and Actos to treat adult type 2 diabetes patients who have not been able to control their blood sugar levels with just insulin. A panel advising the European Medicines Agency had recommended approval for the new use last month.

The FDA approved the same expanded use last fall.

San Diego-based Amylin and Indianapolis-based Lilly said patients taking Byetta with insulin achieved better blood sugar control without weight gain or an increased risk of their blood sugar levels dropping too low compared to patients using just insulin.

Byetta, or exenatide, is a twice-a-day injection. It was first approved in Europe in 2006.

Amylin and Lilly announced in November that they are ending their collaboration on Byetta and its successor, Bydureon, which is designed to be taken once per week. The two companies have already ended their partnership in the U.S., and Amylin will take over marketing of Byetta outside the U.S. by the end of 2013.

Shares of Lilly edged up 2 cents to $39.83 in early trading Friday, while Amylin's stock rose 8 cents to $15.49, paralleling slight gains made by the Nasdaq exchange.


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