
  


Information Request Email, November 18, 2011 - Hyqvia



 
From: Shields, Mark
Sent: Friday, November 18, 2011 1:13 PM
To: 'Maruya, Aiko'
Cc: Blackshere, Angela L
Subject: 125402/0 Information Request -  Baxter Immune Globulin Infusion 
(Human), 10% with Recombinant Human Hyaluronidase
Our Reference:  BL 125402/0

Baxter Healthcare Corporation
Attention:  Ms. Aiko Maruya  
November 18, 2011

Dear Ms. Maruya:

We are reviewing your June 30, 2011 biologics license application (BLA), for 
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase.  We 
have a request for additional information to continue or review:

Product/Assay Development

Please give us an update on the status of assay development for identifying 
isotypes anti-rHuPh20 antibodies in human plasma.

Nonclinical:
Regarding report R09050 (39 week study in ---(b)(4)------ monkeys):
  Upon microscopic examination, an increase in the incidence of cysts in several 
  tissues when compared to controls was seen, such as thyroid/parathyroid, 
  stomach, and in the thymus.  Please address the nature of these findings and 
  why they were not considered test article related or relevant.
  Please comment on the findings of mononuclear infiltration in myocardium.  Do 
  you attribute it to immune complex deposition?  Due to antibody formation in 
  all dose groups lack of dose-response may not be highly informative in this 
  case.
  Please comment on possible causes of erythrocytosis in mandibular lymph nodes.

Regarding reports R09050 and R09058 and/or any other supporting data:
  Please comment how the anti-PH20 neutralizing antibody formation in males and 
  females would affect egg fertilization. 
   

The review of this submission is on-going and issues may be added, expanded 
upon, or modified as we continue to review this submission. 

Please submit your response to this information request as an amendment to this 
file by December 16, 2011 referencing the date of this request.  If you 
anticipate you will not be able to respond by this date, please contact the 
Agency immediately so a new response date can be identified.

If we determine that your response to this information request constitutes a 
major amendment, we will notify you in writing. 

The action due date for this file is April 29, 2012.

If you have any questions, please contact me at (301) 827-6173.

Sincerely,
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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