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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Letter to CSL Behring AG - Hizentra, December 17, 2009

To: Paul Hartmann
CSL Behring AG
Date: December 17, 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.

At least in one site our inspection revealed that the clinical site did not always calculate the actual dose of the investigational medicinal product (IMP) for at least 12 subjects enrolled in the study. Training records at the site included the PowerPoint presentation slides describing the calculation of the final verification dose of the IMP administered to study subjects. However, we note that for the 12 subjects, the IMP dose entered in the subject’s diary did not agree with the dose calculated and/or the dose was not calculated in some instances. 

  1. Please describe:
    1. if the monitor verified the dose discrepancies during monitoring visits and if so, how and when did the monitor reconcile the discrepancies;
    2. how many clinical sites had similar dose discrepancies, if any; 
    3. if all study sites received training for the IMP dose verification and reconciliation.
  2. Based on the question 1, please provide a list of subjects with dose variances including the site #, subject #, diary dose, and verification dose. 

Please submit a response to this request as an amendment to the file by December 23, 2009. 

Thank you.

Pratibha Rana