Headline Event - Victoza approval could pave the way for Byetta LAR approval
Source EP Vantage
Company Amylin PharmaceuticalsAlkermesEli Lilly 
Date February 04, 2010
 

The approval earlier this month of Novo Nordisk’s second generation GLP-1, Victoza, was taken as a signal that the other newer drugs in this class waiting in the wings also stood a good chance of making it to market, in particular Amylin Pharmaceuticals and Eli Lilly’s Byetta LAR, which is expecting a decision by the March 5 PDUFA date (update note: PDUFA delayed by one week to March 12).

Indeed confidence that the others might now make it past the regulator was demonstrated by the fact that rather than sending shares in companies developing rival products down, news of Victoza’s approval sent them up, including an 9% rise in Amylin’s shares on the day. This indicates that many believe the GLP-1 class as a whole has been slightly de-risked in regulatory terms (Victoza's victory could be short lived, January 26, 2010).

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