Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Co. (LLY) said the European Commission has granted marketing authorization to BYETTA as an adjunctive therapy to basal insulin, with or without metformin and/or Actos, for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The company noted that patients in the pivotal study achieved better glycemic control overall and after meals.
"The marketing authorization for the use of BYETTA with basal insulin provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said Christian Weyer, senior vice president, research and development, Amylin Pharmaceuticals. "In a clinical trial, patients using fixed-dose BYETTA with titrated basal insulin achieved better postprandial and overall glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using titrated basal insulin without BYETTA."
The main study included in the EU marketing authorization submission package was a double-blind, 30-week clinical trial published in Annals of Internal Medicine.
Further, as part of the transition plan outside the U.S., Amylin will assume responsibility for exenatide product commercialization efforts on a market-by-market basis by the end of 2013.
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