Amylin, Lilly and Alkermes can smile a little broader today as an expert EU panel has recommended that Bydureon - the long-lasting Type 2 diabetes drug - be approved. The EC still has to formally approve it but usually follows the panel vote.
So while the companies wait on the FDA to come to a similar conclusion - having been sent back to the clinic for more safety data last year - they can look to getting starting with marketing in Europe. The challenge in Europe will come from Novo Nordisk's Victozza -- another GLP-1 drug like Bydureon.
Again, this is much needed good news for the three companies and cause for their celebration I'm sure. See Fierce Biotech.
Posted by Bruce Lehr April 15th 2011.
More on this from Xconomy
http://www.xconomy.com/san-diego/2011/04/15/amylin-alkermes-shares-jump-as-eu-regulators-recommend-diabetes-drug/
Posted by: bigredbruce | 04/15/2011 at 11:45 AM