
Information Request Email, December 21, 2011 - Hyqvia

 
 
From: Blackshere, Angela L [Angela_Blackshere@baxter.com]
 Sent: Wednesday, December 21, 2011 1:45 PM
 To: Shields, Mark; Maruya, Aiko
 Cc: Reed, Jennifer; Scott, Dorothy
 Subject: RE: 125402/0 Immunogenicity comments - Baxter Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

Dear Mark:

Thanks for your response.  FYI…Baxter provided an update on ongoing studies characterizing the isotype of anti-rHuPH20 antibodies in the response that we submitted to FDA on Friday, Dec. 16, 2011.  Please refer to the response to FDA’s Nov. 18, 2011 question:

Product/Assay Development

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

Also note that Baxter plans to submit preliminary data from the (b)(4)bridging assay to study binding of rHuPH20-directed antibodies to HYAL1 and HYAL2 and our Phase 1 data from the tissue cross-reactivity panel in January prior to the teleconference we’d like to have with FDA the week of Jan. 23, 2012.

Mark, if you have not already done so, please forward Baxter’s Dec. 16, 2011 response to Dr. Reed.  I will be in contact with you in January to set up the next teleconference.

Best regards and hope you have a wonderful holiday season,

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: Wednesday, December 21, 2011 10:27 AM
 To: Blackshere, Angela L
 Cc: Reed, Jennifer; Scott, Dorothy

Subject: RE: 125402/0 Immunogenicity comments - Baxter Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

Hi Angela,

We request an update on your ongoing studies characterizing the isotype of anti-rHuPH20 antibodies, and an update of data you have collected using the (b)(4) bridging assay to study binding of rHuPH20-directed antibodies to HYAL1 and HYAL2.

After reviewing these data will will provide additional comments.

We will also provide comments after receipt of interim Phase 1 data for your tissue cross-reactivity panel, which we expect to receive in first quarter 2012.

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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