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Information Request Response Email, May 3, 2012 - Hyqvia



 
From: Blackshere, Angela L [Angela_Blackshere@baxter.com]
Sent: Thursday, May 03, 2012 11:39 AM
To: Shields, Mark
Cc: Hunt, Douglas M
Subject: RE: Information request: Immunogenicity Issues STN 125402/0

Dear Mark:

I acknowledge receipt.

Best regards,

Angela

From: Shields, Mark [mailto:Mark.Shields@fda.hhs.gov] 
Sent: Thursday, May 03, 2012 6:47 AM
To: Blackshere, Angela L
Cc: Hunt, Douglas M
Subject: RE: Information request: Immunogenicity Issues STN 125402/0

Our Reference: BL125402/0

Baxter Healthcare Corporation

Attention: Angela Blackshere

Sent by email

Dear Ms. Blackshere:

We are responding to your email inquiry sent Tuesday, April 17, 2012 7:10 PM. 
(Attached below)

Please acknowledge receipt.

1) Does the email sent by Jen Reed below serve as the official IR letter from 
FDA?

Yes, the email serves as the official IR.

2) Is there a date that FDA is expecting Baxter to provide our proposal by to 
respond to Jen Reed’s point # II below?  [Point II:  Baxter should propose 
preclinical studies in relevant animal species and/or clinical studies to 
address these issues.]

Forwarding your proposal as soon as possible will be helpful. This will speed 
our progress in seeking expert advice (see item 4, below). 

3) Does FDA have any further thoughts we should consider as we prepare our 
proposal?

The main goal is to propose preclinical studies that will provide additional 
information about whether high titer anti-hyaluronidase antibodies could 
interfere with fetal and pediatric neuronal or reproductive development over the 
longer term.  Impact on adults should also be considered.  The choice of animal 
should be justified on the basis of antibody tissue-cross reactivity in testes 
and enteric plexus.  We have internally discussed the value of a chronic 
lifetime study for toxicity assessment, designed with intermittent look-in 
periods, for example histopathological assessment at defined timepoints.  For 
fetal developmental studies, we note that guinea pigs are considered as a 
reasonable model of human transplacental transfer of antibodies, but primates 
have also been used.   However, we encourage Baxter to propose what you have 
determined to be optimal studies to achieve the stated goals.

4) Has FDA had any further discussions/thoughts regarding an anticipated date 
for the BPAC meeting?

We are currently discussing a different (non-BPAC) route for seeking expert 
advice on what studies would best provide data to address our immunogenicity 
concerns.  CBER is planning to request three Special Government Employees (SGEs) 
who are experts, to assist in identifying appropriate studies and in evaluating 
your proposal.

5) Is FDA’s intention when approaching BPAC to request guidance on what data 
Baxter should provide to address your immunogenicity concerns or will FDA 
provide a position on the approvability of the file and ask for BPAC 
concurrence?  Can FDA provide an idea of the type of questions you are planning 
to propose to BPAC?

Our current intention is to obtain expert opinion on preclinical data needed 
from Baxter to sufficiently address immunogenicity concerns.  The need for BPAC 
at a later date would depend upon results of these studies.   If FDA has 
concerns about results of studies, we may ask the BPAC for their opinion on 
approvability of the file at some future date.

Best Regards,

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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From: Blackshere, Angela L [mailto:Angela_Blackshere@baxter.com] 
Sent: Tuesday, April 17, 2012 7:10 PM
To: Shields, Mark
Cc: Hunt, Douglas M
Subject: FW: Information request: Immunogenicity Issues

Dear Mark:

This is a follow-up to the April 5 FDA teleconference and the April 11 FDA 
correspondence below:

1) Does the email sent by Jen Reed below serve as the official IR letter from 
FDA?

2) Is there a date that FDA is expecting Baxter to provide our proposal by to 
respond to Jen Reed’s point #II below?

3) Does FDA have any further thoughts we should consider as we prepare our 
proposal?

4) Has FDA had any further discussions/thoughts regarding an anticipated date 
for the BPAC meeting?

5) Is FDA’s intention when approaching BPAC to request guidance on what data 
Baxter should provide to address your immunogenicity concerns or will FDA 
provide a position on the approvability of the file and ask for BPAC 
concurrence?  Can FDA provide an idea of the type of questions you are planning 
to propose to BPAC?

Best regards,

Angela

*************************************

Angela Blackshere
Sr. Director, Global Regulatory Affairs
Baxter Healthcare Corporation, Baxter BioScience
One Baxter Way
Westlake Village, CA 91362
(805) 372-3050/Phone
(805) 372-3052/Fax
angela_blackshere@baxter.com

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