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 Corporations 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 Corporations Coagulation factor IX (recombinant).

 

Thank you,

Mikhail

 

 

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 

methods

 

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 time.

 

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

