February 27, 2007
Xolair apprehension
Analysis of:
FDA Orders Black Box Anaphylaxis Warning for Omalizumab (Xolair) | www.medpagetoday.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Implications: There is a concern about anaphylaxis secondary to Xolair administration and this may result in longer waiting times after the administration of the drug.
Analysis: If there is a black box warning placed on Xolair, this would imply a 2 hour waiting time after drug administration. This would result in a significant fall off of patients receiving the drug secondary to this waiting period. I am not sure if the black box warning will actually take place as of yet and Genentech is planning a rebuttal to present to the FDA according to the recent meeting at the AAAAI in San Diego.
Analysis: If there is a black box warning placed on Xolair, this would imply a 2 hour waiting time after drug administration. This would result in a significant fall off of patients receiving the drug secondary to this waiting period. I am not sure if the black box warning will actually take place as of yet and Genentech is planning a rebuttal to present to the FDA according to the recent meeting at the AAAAI in San Diego.
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