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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, February 7, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Thursday, February 07, 2013 10:29 PM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Hu, Jiang (Jessica) (CBER) (Jiang.Hu@fda.hhs.gov); Ovanesov, Mikhail V.; Omokaro, Stephanie
Subject:                          Information Request for BL 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We are providing the following comments and request for additional information to continue our review:
 
1.     In the interim analysis report, the annualized bleeding rate (ABR) of on-demand cohort was stated as “35.19 (± 19.22)” (page 76, the last paragraph). However, in the final study report, the ABR of on-demand cohort was stated as “33.87 (± 17.37)” (Page 75, the last paragraph). Please explain why the ABR of on-demand cohort changed in the final study report.
 
2.     We recommend you conduct the baseline comparison between the prophylactic cohort, the on-demand cohort, as well as the historical control group to demonstrate the ”substantial baseline differences” between the prophylactic cohort and the on-demand cohort as well as show comparability to the historical control group. 
 
3.     Please explain why in Section 11.4.1.4.1, the ABR of on-demand cohort was compared with these subjects’ own historical bleed rates.
 
4.     Please include the z-test result, as well as the corresponding confidence interval, in the final study report. The conduct of the z-test should follow the pre-specified statistical analysis plan.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this application. 
 
Please submit your response to this information request as an amendment to this file by February 28, 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.
 
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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