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18 Apr 2011

Lilly & Amylin Receive EU Recommendation for Bydureon

Bydureon, a long-acting form of the daily drug Byetta, has received EU recommendation which is very important for Eli Lilly and Amylin.

An EU expert panel has recommended approval of Eli Lilly, Amylin Pharmaceutical and Alkermes' one-weekly Type 2 diabetes treatment Bydureon, a long-acting form of the daily drug Byetta.


The recommendation is very important for the companies. The FDA denied approval of Bydureon last year over concerns about how the drug can build up in the body. Regulators now await new safety study data to address cardiovascular concerns, delaying a U.S. launch until at least mid-2012.


The European Commission doesn't always follow the panel's recommendation, although it usually does. If approved, Bydureon will compete with Novo Nordisk's Victoza. Both drugs are part of the GLP-1 drug c

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