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Vaccines, Blood & Biologics

First Committee Meeting, January 18, 2013 - RIXUBIS


From: Ovanesov, Mikhail V.
Sent:    Wednesday, January 30, 2013 4:25 PM
To:      Thompson, Edward
Subject:           summary of the Mid-Cycle meeting for STN 125446/0 Baxter
Healthcare Corporation’s Coagulation factor IX (recombinant).
Dear Edward,
This email will serve as an official summary of the Mid-Cycle meeting for STN 125446/0 Baxter
Healthcare Corporation’s Coagulation factor IX (recombinant).
Thank you,
Meeting Summary:
Subject: Mid-Cycle Meeting for STN 125446/0   Baxter Healthcare Corporation
                        Coagulation factor IX (recombinant) _ Original BLA
Location:                        CBER Conf. WOC 1 583
Start:                              Fri 1/18/2013 9:30 AM
End:                                Fri 1/18/2013 11:00 AM
Required Attendees:     Thompson, Edward; Ovanesov, Mikhail V.; Amin, Pankaj (Pete);
Campbell, Karen M; Hu, Jiang (Jessica) (CBER); Jordan, Carla;
Mahmood, Iftekhar; Nguyen, Loan; Omokaro, Stephanie; Shields,
Mark; Drews, Roman T; Baer, Bethany; Pilaro, Anne
Optional Attendees:      Lee, Timothy; Jain, Nisha; Golding, Basil; Chazin, Howard; Farshid,
Mahmood; Mintz, Paul; Peng, Ze; Valencia, Iliana; Williams, Alan;
Jett, Betsy; Giglio, Joseph; Rees, Renee
Drafted:         Edward Thompson
Revised:          Mikhail Ovanesov
STN: 125446/0
Applicant: Baxter Healthcare Corporation
Product: Coagulation factor IX (recombinant)
Short Summary: Routine prophylaxis, preoperative management, control and
prevention of bleeding episodes in patients –b(4)--- and older with hemophilia B.


The goal of the Mid-cycle meeting was to have a comprehensive reading on the state of the
review. This included:
1.   Identifying any informational requests (IRs). 
Response: Several clinical, CMC and statistical IRs were identified. They will be forwarded to RPM for preparation
2. Identifying issues that could prevent approval. Response: The following preliminary issued were identified for further discussion: 
*    CMC = Stability OOS events, differences between FIX activity testing (APTT-
based) at release and in clinical trials, 40% increase in activity measurement
reported by DBSQC for tested conformance lots, impurity levels in product (FIXa
and furin), and viral testing using in –b(4)---------------------------------------------------------------------------------------
*    Clinical = Concerns with antibody production against the furin impurity, question
on clinical risk associated with this impurity, and the increased level of
thrombosis risk
*    Statistical = Inconsistencies of the P-test and T-test data submitted in the
Preliminary and Final clinical study reports
*    DBSQC consult reviewer = validation of sterility/bioburden and endotoxin
3.    Identifying any problems. 
Response: Same as item # 2
4. Develop a clear plan for addressing any problems.
      Response: Prepare information request and discuss internally. A follow up meeting with management (Drs. Basil Golding and Nisha Jain) will be scheduled at 2:00pm on 18 January 2013 to discuss issues from item #2. Additional information may be gathered during pre-approval inspection.
5. Making any recommendations for review to go to an advisory committee if  necessary. 
Response: Will be discussed at a meeting with Drs. Basil Golding and Nisha
Jain at 2:00pm on 18 January 2013. Conclusions from the 2:00pm meeting: a thorough
review of clinical data is needed but going to an advisory committee is unlikely at this
6. Determine Lot Release requirements: Samples and test protocols submissions and the lot release testing plan. 
Response: Not required for recombinant product
7. Ensure UNII Code process is initiated. 
            Response: RPM will arrange a meeting with Vada Perkins
8.   Ensure PeRC presentation date is scheduled, the PeRC forms have been submitted.(2 weeks before PeRC meeting), and clinical reviewer has addressed waiver/deferral of PREA decision. 
            Response: Product is Orphan Designated
9.         Determine if PMCs, PMRs or a REMS are required. 
            Response: PMC related to the stability program was proposed by Baxter. Others may be determined when appropriate
10.       Determine NDC assignments to product/packaging.
             Response: RPM will arrange a meeting with Vada Perkins and label meeting
11.       Determine proper name convention. 
            Response: Currently agreed with the name “Coagulation Factor IX (Recombinant)”
End of Summary

Page Last Updated: 08/06/2013
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