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July 25, 2007

What are the potential ramification for Avandia following the FDA Advisory Committee?

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Michael Davidson, MD, FACC, Director, Preventive CardiologyMichael Davidson, MD, FACC
Director, Preventive Cardiology, The University of Chicago
Implications: It appears from the breifing documents that the FDA has concerns about the CV safety of Avandia. They appear to be less concerned about the CV safety of Actos but both drugs are associated with an increase risk of heart failure. It is unknown how the Advisory Committee will vote but based on the available information there is likely to be some labeling change for Avandia (possibly a black box for more than CHF) than could put it at significant commercial disadvantage to Actos or Januvia.

Analysis: Therefore a negative Advisory Committee vote on any of the issues will adversely affect GSK but may help MRK and to a lessor extent Takeda (depending on how the safety of the TZD class is perceived)


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