Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 25-Nov-2011 01:52 PM Initiated by FDA? No
Telephone Number: firstname.lastname@example.org
1. Other - GSK status update
Author: KIRK PRUTZMAN
GSK updates on validation data and plans to change to a diluent-Vial presentation
FDA Participants: JOSEPH TEMENAK, DAVID STATEN, KIRK PRUTZMAN
-FDA Participants: JODY GOULD
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Jody Gould emailed Joseph Temenak, David Staten and Kirk Prutzman.
From: Jody Gould [email@example.com]
Sent: Friday, November 25, 2011 2:28 PM
To: Temenak, Joseph
Cc: Staten, David; Prutzman, Kirk C
Subject: Fwd: MenHibrix - STN/BL 125363 - information to be submitted with the CR Letter response
Attachments: PMCs MenHibrix (4).pdf; ATT00001.htm
As you requested during our phone call on Wednesday, this email summarizes the items GSK is planning to include with the CR letter response submission on November 30.
Additional validation data requested by CBER in the June 2010 CR Letter. In our April 15 2011 response to the first CR letter, GSK indicated that additional validation data requested in Items 39a, 40b, 42 (b,d,f,i,h), 43 (b,e,g), 44 (a,c), 45 (a,c,g,f), and 49 would be submitted post-approval (which was anticipated in 4Q 2011 at that time). Because these data are available now, we plan to include them in the November 30 submission. Please refer to the attached table which summarizes the available data.
Diluent in vials. As described in our recent supplemental submission to the Hiberix BLA, GSK is replacing diluent –b(4)----------------------- with diluent in vials for lyophilized injectable vaccine products marketed in the US. This is based on previous discussions with CBER which communicated the requirement for administration of a measured amount of reconstituted vaccine. GSK believes diluent in vials offers the best solution to meet the measured withdrawal requirement, as it allows control of the amount of diluent used for reconstitution and the amount of reconstituted vaccine administered. Note that GSK no longer has a contract with –b(4)-------------, who supplied –b(4)- and that GSK's –b(4)- supplies are limited. Consequently, even with the expected ‘permissive’ recommendation from CDC, diluent in vials is needed to provide sufficient launch supplies. Note also that the information that will be provided to the MenHibrix file (updates to modules 2 & 3 documents and PI changes) is identical to what was included in the sBLA for Hiberix (11/21/11). So there is an opportunity for parallel review of the information in both files.
Please contact me at 610-639-65997 to discuss. Thanks again for your help.
Jody Ann Gould, PhD
US Regulatory Affairs
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