
Minutes of Telephone Conference, October 12, 2010 - MenHibrix

 
 

Date: 
12 October 2010 

To:
STN 125363 FDA Regulatory File 

From: 
David C. Staten, Jr., MPH, CDR, USPHS
BLA Regulatory Project Manager 

Through:

Joseph Temenak, Ph.D., CDR, USPHS 
BLA Chairman
 

Subject:
Record of FDA and GlaxoSmithKline October 6, 2010 Telephone Conference 

Reference: 
Item 67 (c, d, and e) Complete Response Letter 

Participants: 
  

CBER:

Jennifer Bridgewater
Daron Freedberg
Rajesh Gupta
Tina Roecklein 
David Staten 
Liz Sutkowski 
Joseph Temenak 
Willie Vann
 

GSK:

Nancy Cauwenberghs, Director, Technical Regulatory Unit
Jean-Francois Dierick, Manager, QC Biochemistry 
Jody Gould, Director, Vaccines, North American Regulatory Affairs 
Kalliopi Grigoriadou, Scientist, Technical Regulatory Unit 
Dominique Labbe, Expert Scientist, Analytical R&D 
Olivier Laloux, Director, Analytical R&D 
Christophe Lenfant, Senior Project Manager, Analytical R&D 
Norris Pyle, Assistant Director, Vaccines, North American Regulatory Affairs 
Catherine Vigano-Wolff, Scientist, Technical Regulatory Unit 
Xavier Raquet, Senior Scientist, Technical Regulatory Unit
 

This telephone conference was requested by GSK to discuss their response to Item 67 from the June 11, 2010 FDA Complete Response letter. GSK specifically wanted to discuss the request for the addition of free HIB, MenC, and MenY free polysaccharide content on the MenHibrix final container vaccine. GSK proposed to replace the requested –b(4)-- assay with a (b)(4) by --------(b)(4)----------. As presented in their PowerPoint presentation, GSK would like to use this assay for the following reason;
1.The free-PS content test by (b)(4) is not accurate for polysaccharides of -(b)(4)-.
2.Free-PS content by ---------(b)(4)--------- has been developed to replace free-PS content test by (b)(4) on the three monovalent (b)(4) conjugates, Hib-TT, PSC-TT, and PSY-TT.
3.The presence of sucrose --(b)(4)-- in the final container interferes with the PS quantification by --------(b)(4)----------.
4.Free-PS content tests are not enough specific/sensitive/accurate/robust to be implemented on MenHibrix final container.

GSK showed data that --------(b)(4)---------- in final product was able to detect degraded conjugates. GSK confirmed that degraded conjugates were not tested in clinical trails.

FDA stated that there are two approved products that currently have a free PS content assay on the final container. GSK explained that MenHibrix is different from these products because MenHibrix is lyophilized and the conjugates are –b(4)---- polysaccharides. FDA suggested more exploration of techniques, for example, --------------(b)(4)---------------- .

Restating the points above, GSK stated that a valid free-PS content assay can not be used. Instead, GSK wants to implement a --------------(b)(4)---------- ---- for the final container. GSK asked if FDA concurs with this proposal. FDA stated that the agency has insufficient data to make any decision regarding this change in ---(b)(4)--- for the final container. GSK stated that additional justifications as to why they prefer the --------(b)(4)---------- method will be submitted. These data will be submitted in the CR
