
  


Information Request Email, September 8, 2011 - Hyqvia




  

 
From: Shields, Mark
Sent: Thursday, September 08, 2011 12:16 PM
To: 'Aiko_Maruya@baxter.com'
Cc: 'Angela_Blackshere@baxter.com'
Subject: 125402/0 Baxter Immune Globulin Infusion (Human), 10% with Recombinant 
Human Hyaluronidase, Original BLA - Information Request

Hi Aiko,

This email conveys our request for additional information regarding your 
submission for STN 125402/0 that was submitted to the agency on June 30, 2011, 
as an Original Biologics License Application for Immune Globulin Infusion 
(Human), 10% with Recombinant Human Hyaluronidase.
  Please cross-reference or provide to CBER any tissue cross-reactivity studies 
  you have performed related to the binding of anti-rHuPH20 antibodies in a 
  normal human tissue panel.

Rationale:

Your immunogenicity risk analysis presents an argument that anti-PH20 antibodies 
are unlikely to bind to other human hyaluronidases, on the basis of low overall 
sequence homology (33-42%). However Chan et. al. (1999) demonstrated that a 25 
residue PH20 peptide bearing epitopes associated with fertility suppression in 
guinea pigs was 84-88% homologous in PH20s of various species, and was 70 to 77% 
conserved in HYAL2 and HYAL4 of humans based on our own analysis. Thus the 
likelihood of anti-PH20 binding to other human hyaluronidases might be higher 
than has been previously considered. An evaluation of tissue deposition of 
anti-PH20 antibodies in a normal human tissue panel (including both male and 
female tissues) would help to clarify PH20 expression particularly in tissues 
from females, and suggest whether anti-PH20 has the potential to bind other 
tissue hyaluronidases, for example, those found in bone and joint. We feel this 
information could refine post-marketing surveillance activities and ensure that 
potentially debilitating consequences of PH20 immunogenicity are identified 
promptly.

Please respond to the request by September 26, 2011.

Please reply to confirm receipt of this information request.

Thanks!
Mark A. Shields, RAC 
Regulatory Project Manager 
HFM-380  FDA/CBER 
Office of Blood Research and Review 
Division of Blood Applications 
301-827-6173 fax 301-827-2405 
email: mark.shields@fda.hhs.gov 
1401 Rockville Pike 
Rockville, MD 20852-1448

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