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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, January 29, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Tuesday, January 29, 2013 3:30 PM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Ovanesov, Mikhail V.; Mahmood, Iftekhar
Subject:                          Information Request for BL 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smythe:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We are providing the following clinical pharmacology comments and request for additional information to continue our review:
 
Reference Clinical Study #250901:
 
There are discrepancies in data provided in PK Tables.  Please provide explanation for these discrepancies:
 
  • Table 6 vs Table 8: Discrepancies in AUC(0-72) and AUC(0-infinity) values in study part 1 for BAX326 and BeneFIX
  • Table 7 vs Table 9: Discrepancies in AUC(0-72) and AUC(0-infinity) values in study part 1 for BAX326 and BeneFIX
  • Please provide a 90% confidence interval comparing your pilot vs commercial product.
  • Is it correct that you used pilot formulation in part 1 of the study and commercial formulation in part 3 of the study?  If not please explain.
  • Please provide a mean concentration-time plot for BAX326 on linear and log10 scale comparing it with BeneFIX.
  • Please provide a mean concentration-time plot for BAX326 on linear and log10 scale in studies part 1 and 3 (a comparative single plot).
 
      Reference Clinical Study #251002:
 
      Please provide individual concentration-time PK data and individual and mean concentration-time plots.
 
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 February 12, 2013 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 tentatively June 30, 2013.
 
Please send an acknowledgement message for receipt of our request.
 
If you have any questions, please contact me at (301) 827-9167.
 
Sincerely,
 
 
Edward Thompson
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
 
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