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Vaccines, Blood & Biologics

First Committee Meeting - March 31, 2009 - Hiberix

Hiberix – STN 125347/0
First Committee Meeting
March 31, 2009


  1. Review milestones
  2. Discuss review assignments
  3. Discuss review strategies
Application Received:March 17, 2009
Committee AssignmentMarch 24, 2009
1st Committee MeetingMarch 31, 2009
Filing MeetingApril 1, 2009 (via e-mail)
Filing Action/Deficiencies IdentifiedApril 16, 2009
Target Action Due Date:July 31, 2009
Committee Assigned: 
ChairJay Slater, M.D.
Committee Members 
Clinical Reviwer/LabelingKaren Farizo, M.D.
Product CMC/SerologyMustafa Akkoyunlu, M.D. Ph.D
Product CMCScott Norris
Product CMCTina Roecklein
Facilities/DMPQJoseph George
Advertising/ Promotional LabelingMaryann Gallagher
Clinical Statistical ReviewerGhideon Ghebregiorgis, Ph.D.
EpidemiologyDavid Menschik, M.D., MPH
DPQ/Lot Testing PlanRajesh Gupta, Ph.D.
Lot ReleaseJoe Quander III
BiMoChristine Drabick, MS
DVRPA ReviewerJoe Temenak, Ph.D.
DVRPA Regulatory Project Mgr.Jason Humbert
DBPAP Regulatory CoordinatorJennifer Bridgewater, MPH

Discussion Items:


Dr. Jay Slater provided an overview of the unique nature of this BLA and the accelerated approval schedule.


Dr. Karen Farizo noted that GSK has submitted a revised concept protocol for Study Hib-097 the day of this meeting, March 31, 2009, but that the concept protocol in the original submission did not incorporate many of CBER’s suggestions provided in the pre-BLA meeting. There are concerns about the confirmatory study protocol and those should be addressed in an A/I letter. In the cover letter to the amendment received March 31, 2009, GSK states that the protocol included in this BLA amendment is being filed to the -b(4)- IND (--------b(4)-------------------------------------------------------------------------------------------------------------------- ----------------------) simultaneously, and requests concurrent review of the protocol in the context of both files. Dr. Farizo stated that the file is acceptable to file, but noted that discussion internally and with GSK will be needed to address concerns with the confirmatory study.


Dr. Mustafa Akkoyunlu noted that the serology included in the BLA appears to be acceptable and the methods are sufficient. There was discussion regarding the assay utilized and whether GMTs are higher with the -b(4)- assays than with the sera assayed by --b(4)--. Dr. Akkoyunlu will attempt to provide Dr. Farizo with information on how these assays compare. This will assist Dr. Farizo in her efforts to assess whether there is consistency across studies.


Joe George has been in discussion with Linda Kramer of GSK regarding the timing of the PAI. The schedule is filled due to Belgian holidays on May 1, 21 and 22, and a previously scheduled inspection from May 19 -28.  The proposed timeframe for the inspection is June 22-July 3, 2009.

Tina Roecklein, Scott Norris and Joe George will be participating in this inspection.

Lot Testing

Dr. Rajesh Gupta indicated that tests to be conducted have been identified. Discussion with Scott Norris, Dr. Akkoyunlu and members of DPQ will continue. Dr. Gupta noted the need to order the samples, as well as any necessary reagents, as soon as possible. Work will continue on the lot release protocol.


Dr. David Menschik noted that there are no deficiencies in the file from his perspective. A question was raised regarding whether a Pharmacovigilance Plan (PVP) was included in the original submission. Dr. Menschik indicated that the PVP could be found in Section 1.1.6.

Clinical Statistics

Dr. Ghideon Ghebregiorgis stated that he has not found any issues which would preclude the BLA from being filed. Dr. Ghebregiogis added that he briefly reviewed the data sets included in the amendment received March 31, 2009 and will be in contact with Dr. Farizo.

Advertising/Promotional Labeling

Maryann Gallagher noted the receipt of the information to support the proposed proprietary name, Hiberix, in the amendment received today, March 31, 2009. All of the labeling and package materials have been included in the submission.

The committee acknowledged that a BiMo inspection will not be needed to support this submission.

Next Step:

A filing meeting will be conducted via e-mail on April 1 and 2, 2009 to seek concurrence that the submission may be filed and to identify any deficiencies to be communicated to the sponsor in the Filing Letter.       


A Filing Letter with or without deficiencies identified will be drafted by the filing action milestone of April16, 2009.

CBER:OVRR:DVRPA: JHumbert: drafted 4-1-09

File:N:\DVRPA\JHumbert\125347 Hiberix\First Committee Meeting_3-31-09 Memo

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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