Market Overview

CHMP Recommends Approval of BYETTA for Use With Basal Insulin

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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.

Posted-In: News FDA

 

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