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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CSL Behring AG Letter - Hizentra, May 21, 2009

To: Paul Hartmann
CSL Behring AG
Date: May 21, 2009

This is regarding your BLA submission STN 125350/0 for Immune Globulin Subcutaneous (Human), 20% Liquid, submitted to the Agency on April 30, 2009.  FDA continues with the review of the referenced submission and requests CSL Behring AG to provide the following information.

  1. In your study, ZLB04_009CR, there were 8 subjects who withdrew informed consent during the wash-in/wash-out period, and an additional 6 subjects during the “efficacy” period. Please provide the narratives of these subjects, and include within it the (a) the reasons for consent withdrawal, and (b) subsequent therapy (?back to IGIV).
  2. During the “efficacy” period of study ZLB04_009CR, there were also one patient with multiple violations leading to dropout, and another dropping out due to non-compliance. Please provide narratives detailing (a) what the incidents were that led to withdrawal, and (b) subsequent therapy (?back to IGIV).

Please submit a response to this request as an amendment to the file by June 5, 2009.  

Thank you.

Pratibha Rana