• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

First Committee Meeting Summary, September 20, 2012, RIXUBIS

 

From:                    Ovanesov, Mikhail V.
Sent:                      Thursday, September 20, 2012 4:00 PM
To:                         Thompson, Edward; Amin, Pankaj (Pete); Campbell, Karen M; Hu, Jiang (Jessica) (CBER); Jordan, Carla; Mahmood, Iftekhar; Nguyen, Loan; Omokaro, Stephanie; Baer, Bethany
Cc:                         Shields, Mark; Drews, Roman T; Austin-Hansberry, Lori; Lee, Timothy; Jain, Nisha
Subject:                 RE: One Day Reminder for 1st Committee Meeting for STN 125446/0   Baxter Healthcare Corporation _Coagulation factor IX (recombinant) _ Original BLA
Dear Edward and review team,
 
This email summarizes the 1st Committee meeting for STN 125446/0   Baxter Healthcare Corporation - Coagulation factor IX (recombinant) - Original BLA
 
Issues discussed at the Committee meeting:
 
  • Ensure the submission is complete.
    Response: Submission is complete. Specifically, CMC (chair), APLB, Statistical, DMPQ, and Epidemiology reviewers noted that submission is fileable.
     
  • Agree the appropriate review level assignment, i.e. a PAS
    Response: Original BLA is appropriate.
  • Ensure a reviewer is assigned to review each section of the application.
    Response: Reviewers were assigned to each section of the submission.
  • Determine if advisory committee meeting is required. If not, then a justification is required in this meeting summary.
    Response: No issues requiring advisory committee participation were identified at this time. Advisory committee meeting is not required because indications for the BLA product reasonably overlap with a existing products of this class which includes one recombinant and several plasma-derived factor IX concentrates.

Final decision regarding the advisory committee meeting can be made at the Filing Meeting (scheduled for Thursday, 10/11/2012).

  • Confirm the review schedule and all future meeting dates. (PeRC and Labeling Meeting)
    Response: Review schedule is acceptable. Note that it may be updated when FDA denies the request for priority review.
  • Identify if consult reviewers are needed in the review process.
    Response: No consult reviewers are needed at this time.
  • Identify any potential issues and confirm adequacy of the data sets.
    Response:
    1.     Inspection related compliance history already requested as information request.
    2.     Statistical part of the submission is not complete at this time, as Baxter submitted the interim data result only.
    3.     Chair: Regarding Baxter’s supporting information provided in the "Request for Priority Review for BLA 125446/0 for the Use of –b(4)---------
    ---- for Prophylaxis Treatment of Hemophilia B Patients", decision was made to deny the request. This decision is supported by Clinical, Epidemiology and CMC reviewers who noted that clinical indications and pharmacological properties of Baxter’s product do not provide significant advantage over existing products on market.
These deficiencies do not prevent the submission from being filed.
  • Determine pre-license or pre-approval inspections are necessary. Identify BiMo inspection sites.
    Response: Two facilities, Baxter Healthcare Corporation –b(4)------------------- and Baxter Healthcare Corporation, --b(4)------------------------------, may be inspected. Decision will be made after the facility-related information including FDA inspection history is reviewed.
  • Identify follow up activities to be completed before the next meeting (Filing Meeting).
    Response: Issues that may require input from the advisory committee should be discussed prior to the Filing Meeting.
 
P.S. Dear reviewers, if you have additional comments on this BLA please send to the Chair (me) and Edward. Thanks a lot!
 
Best regards,
--mikhail
 
Mikhail V. Ovanesov, Ph.D.
Visiting Scientist, Principal Investigator
Laboratory of Hemostasis / Division of Hematology / Office of Blood Research and Review
Center for Biologics Evaluation and Research / U.S. Food & Drug Administration
Office: (301) 827-4026 Fax: (301) 402-2780 Cell: ----b(6)---------------------
E-mail: mikhail.ovanesov@fda.hhs.gov
29 Lincoln Drive, N29/309, Bethesda, MD 20892                                                    
Mail: FDA/CBER ; HFM 340 ; 1401 Rockville Pike, Rockville, MD 20852
 
 
_____________________________________________
From: Thompson, Edward
Sent: Wednesday, September 19, 2012 10:12 AM
To: Thompson, Edward; Ovanesov, Mikhail V.; Amin, Pankaj (Pete); Campbell, Karen M; Hu, Jiang (Jessica) (CBER); Jordan, Carla; Mahmood, Iftekhar; Nguyen, Loan; Omokaro, Stephanie; Baer, Bethany
Cc: Shields, Mark; Drews, Roman T; Austin-Hansberry, Lori
Subject: One Day Reminder for 1st Committee Meeting for STN 125446/0 Baxter Healthcare Corporation _Coagulation factor IX (recombinant) _ Original BLA
 
 
Subject: 1st Committee Meeting for STN 125446/0 Baxter Healthcare Corporation _Coagulation factor IX (recombinant) _ Original BLA
When: Thursday, September 20, 2012 9:30 AM-10:30 AM (GMT-05:00) Eastern Time (US & Canada).
Where: CBER Conf. WOC 1 583
 
STN: 125446/0
Applicant: Baxter Healthcare Corporation
Product: Coagulation factor IX (recombinant)
Short Summary: Routine prophylaxis, perioperative management, control and prevention of bleeding episodes in patients –b(4)----- and older with hemophilia B.
 
Hello,
 
We are holding the first committee meeting for STN# 125446/0 by email. The purpose of this meeting is to:
  • Ensure the submission is complete.
  • Agree the appropriate review level assignment, i.e. a PAS
  • Ensure a reviewer is assigned to review each section of the application.
  • Determine if advisory committee meeting is required. If not, then a justification is required in this meeting summary.
  • Confirm the review schedule and all future meeting dates. (PeRC and Labeling Meeting)
  • Identify if consult reviewers are needed in the review process.
  • Identify any potential issues and confirm adequacy of the data sets.
  • Determine pre-license or pre-approval inspections are necessary. Identify BiMo inspection sites.
  • Identify follow up activities to be completed before the next meeting (Filing Meeting).
 
The filing meeting is scheduled for 12-Oct-12 and will also be held via email unless you feel that a more formal method is required. Please respond to this email thread, which will be used as meeting record.
 
Call in number---b(4)-------------
Passcode: --b(4)----------------
 
Review Schedule attached below:
 << File: 125446.0.ReviewSchedule.pdf >>
 
Thank you,
Edward M. Thompson
Regulatory Project Manager
HFM-380 FDA/CBER
Office of Blood Research and Review
Division of Blood Applications
301-827-9167, Fax 301-827-2857
email: edward.thompson@fda.hhs.gov
1401 Rockville Pike, Room 554N
Rockville, MD 20852-1448