An EU expert panel has recommended approval of Eli Lilly ($LLY), Amylin Pharmaceutical ($AMLN) and Alkermes' one-weekly Type 2 diabetes treatment Bydureon, a long-acting form of the daily drug Byetta. The European Commission doesn't always follow the panel's recommendation, although it usually does.
The recommendation is much-needed good news 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.
If approved, Bydureon will compete with Novo Nordisk's Victoza. Both drugs are part of the GLP-1 drug class. In a recent head-to-head trial, Victoza was more effective at lowering blood sugar than Bydureon, which was still effective and boasted a more convenient dosing schedule.
- check out the Reuters report