


Information Request Email, November 22, 2011 - Hyqvia




 
From: Reed, Jennifer
Sent: Tuesday, November 22, 2011 12:41 PM
To: Shields, Mark; 'Maruya, Aiko'
Cc: Blackshere, Angela L
Subject: RE: 125402/9 Comments -  Baxter Immune Globulin Infusion (Human), 10% 
with Recombinant Human Hyaluronidase
 Our Reference:  BL 125402/9 
 Baxter Healthcare Corporation
 Attention: Ms. Aiko Maruya
 November 22, 2011

Dear Ms. Maruya:
 We have the following comments regarding your November 8, 2011 amendment to the 
biologics license application (BLA) for Immune Globulin Infusion (Human), 10% 
with Recombinant Human Hyaluronidase.

We agree that the project you propose in collaboration with -(b)(4)-, 
“Immunohistochemical analysis of the cross-reactivity of a ---(b)(4)--- 
anti-rHuPH20 antibody in human tissues”, will provide very informative and 
important data that meets our expectations regarding study execution, array of 
tissues evaluated, and number of subjects.
 Please agree to or comment on the following additional studies:
  Please prepare a pooled plasma sample from patients with persistent rHuPH20 
  binding antibodies in study 160603. Please prepare as a control a pooled 
  plasma sample from patients in study 160603 which were negative for rHuPH20 
  binding antibodies. Please evaluate the reactivity of these two samples in the 
  same tissue cross reactivity panel you proposed in the --(b)(4)-- study 
  “Immunohistochemical analysis of the cross-reactivity of a ---(b)(4)------ 
  anti-rHuPH20 antibody in human tissues”.
  Please investigate the binding of the two pooled plasma samples to HYAL1 and 
  HYAL2 using your bridging assay format.

These comments will be up for discussion at our scheduled teleconference 
tomorrow, November 23, 2011.
 Questions or replies to these comments may be directed to me:  
jennifer.reed@fda.hhs.gov, or 301.496.0625.

Sincerely, 
 Jennifer L. Reed, Ph.D.
 Food and Drug Administration
 Center for Biologics Evaluation and Research
 29 Lincoln Drive, HFM-345 Room 302
 Bethesda, MD  20892
 

    