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CHMP Recommends Approval of BYETTA® for Use With Basal Insulin
Date:2/17/2012

SAN DIEGO and INDIANAPOLIS, Feb. 17, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion in the European Union (EU) for the expanded use of BYETTA® (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The CHMP's decision is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on CHMP recommendations within two to three months.

"The combination of BYETTA with basal insulin has potential as a complementary treatment approach for several reasons," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "BYETTA is given in a fixed-dose regimen. Its effects contribute to improved glycemic control after meals, complementing the control of fasting blood sugar achieved with basal insulin. And in a clinical study, patients using BYETTA with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, than patients using insulin glargine without BYETTA."

The double-blind clinical trial evaluating BYETTA as an add-on therapy to insulin glargine was published in Annals of Internal Medicine.[1] In the 30-week study, BYETTA 10 micrograms or placebo was added to existing insulin glargine therapy (with or without metformin, pioglitazone or both), which was titrated to achieve target fasting glucose levels. At study entry, patients wh
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SOURCE Amylin Pharmaceuticals, Inc. and Eli Lilly and Company
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