
Interpretation Clarification Email, August 29, 2012 - Hyqvia


From: Shields, Mark
 Sent: Wednesday, August 29, 2012 9:45 AM
 To: Blackshere, Angela L
 Cc: Kuchimanchi, Kamesh V
 Subject: FW: Clarification Question Re: Action Letter for 125402/0 

Attachments: 2012-07-27 LTRIN FDA CR Letter 125402_0.pdf

Hi Angela,

The agency agrees that your interpretation is correct.

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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--------------------------------------------------------------------------------

From: Blackshere, Angela L [mailto:Angela_Blackshere@baxter.com] 
 Sent: Monday, August 20, 2012 6:53 PM
 To: Shields, Mark
 Cc: Kuchimanchi, Kamesh V
 Subject: Clarification Question Re: Action Letter for 125402/0 

Dear Mark:

Baxter has the following clarification question regarding the reference to 
“immunotoxicity” in comment 2.b. in the FDA complete response letter for STN 
125402 (attached) and can FDA respond by end of next week, Fri. Aug. 31:

The Complete Response Letter (CRL) for Immune Globulin Infusion (Human), 10% 
with Recombinant Human Hyaluronidase (STN 125402) dated July 27, 2012 indicates 
that the BLA did not include sufficient information on the potential toxicities 
of anti-PH20 antibodies in select patient populations, particularly in regard to 
enteric plexus and male reproductive tissue and male and female fertility. 
However, question 2.b. also refers to the “possible developmental immunotoxicity 
of the proposed product.” Since the term ‘immunotoxicity’ can be interpreted to 
refer to adverse effects on the immune system, as described in FDA Guidance 
document ‘Immunotoxicology Evaluation of Investigational New Drugs’, 
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079239.pdfi
), clarification of question 2.b. is requested. 

The interpretation of ‘immunotoxicity’ to refer to adverse effects on the immune 
system would appear to be inconsistent with the context of the CRL questions or 
with prior communications with the Agency. Thus, Baxter believes the sentence: 

“The BLA does not contain sufficient information on possible developmental 
immunotoxicity of the proposed product.” 

should be interpreted as:

“The BLA does not contain sufficient information on the possible developmental 
toxicities associated with exposure to anti-PH20 antibodies in the developing 
fetus and the young.”

Does FDA agree?

Thank you and 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.co

From: Blackshere, Angela L 
 Sent: Monday, August 06, 2012 2:20 PM
 To: 'Shields, Mark'
 Cc: Kuchimanchi, Kamesh V
 Subject: RE: Action Letter for 125402/0 

Hi, Mark:

FYI…the attached letter was submitted today via the electronic gateway to inform 
FDA that Baxter intends to submit an amendment to respond to the complete 
response letter.

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 

From: Shields, Mark [mailto:Mark.Shields@fda.hhs.gov] 
 Sent: Monday, July 30, 2012 10:05 AM
 To: Blackshere, Angela L
 Subject: Re: Action Letter for 125402/0 

I just faxed it. 

From my Blackberry

From: Blackshere, Angela L [mailto:Angela_Blackshere@baxter.com] 
 Sent: Monday, July 30, 2012 12:38 PM
 To: Shields, Mark 
 Cc: Kuchimanchi, Kamesh V kamesh_kuchimanchi@baxter.com; Hunt, Douglas M 
douglas_hunt@baxter.com 
 Subject: RE: Action Letter for 125402/0 

Hi, Mark:

I am back in the office today. Baxter still has not received the action letter 
for STN 125402. Can you provide an update regarding when it will be sent? Thank 
you.

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 

From: Blackshere, Angela L 
 Sent: Tuesday, July 17, 2012 4:52 PM
 To: 'Shields, Mark'
 Cc: Kuchimanchi, Kamesh V; Hunt, Douglas M
 Subject: Action Letter for 125402/0 

Dear Mark:

The action date for Baxter’s BLA for Immune Globulin 10% (Human) with 
Recombinate Human Hyaluronidase (STN 125402) is July 29, 2012, so we anticipate 
that FDA will send the action letter by Friday, July 27, 2012. I will be out of 
the office next week, so I ask that you please either email (with copy to Doug 
Hunt) or fax at 805-372-3052 the action letter to the attention of Kamesh 
Kuchimanchi, PhD, Associate Director, Regulatory Affairs. Dr. Kuchimanchi can 
also be reached at the Baxter office at (805) 372-3190 or by cell phone at 
---(b)(6)----.

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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