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From: Blackshere, Angela L [Angela_Blackshere@baxter.com]
Sent: Friday, March 09, 2012 4:17 PM
To: Landow, Laurence
Cc: Shields, Mark
Subject: RE: 125402.0 Revised labeling - PK Figure 1

Dear Dr. Landow:

Regarding your comment related to the PK Figure 1 in the HyQvia package insert 
(v 4), “Please change the plot to reflect the mean of all subjects’ data, rather 
than a single subject”:

The group here at Baxter had the same initial comment that you did. 
Unfortunately, this is more challenging than we had imagined as the subjects had 
different dose adjustments for both IV and for subcutaneous administration of 
HyQvia. Therefore, unfortunately our baseline isn’t the same for all patients. A 
representation of the mean is therefore only possible, if we adjust them all to 
the same baseline. This of course is very different than when evaluating a small 
molecule where the baseline is always zero.

We considered accounting for these baseline differences by plotting percent 
recovery. However, as most PIDD subjects produce some IgG, the levels vary and 
cannot be determined without interrupting treatment for several months or using 
radio-labeled product; neither of which is an option.

A further option considered was that Linear scaling would remove the intrinsic 
IgG level, however as the PK of IgG is known to be non-linear, this does not 
seem to be appropriate.

We think that the graphical representation of this data remains the clearest 
presentation and would welcome your thoughts on alternate options. We will go 
back to the team here and see what they all recommended. Finally, we would be 
happy with providing all the individual plots for you to select either the 
extent of the range or an appropriate representative plot.

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: Thursday, March 08, 2012 9:29 AM
To: Blackshere, Angela L
Cc: Campbell, Diane
Subject: 125402.0 Revised labeling

Hi Angela,

Please find attached the revised package insert for Hyqvia This iteration 
reflects the edits attached to your email received on 7-MAR-2012.

Please submit your next version as an amendment to the BLA.

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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