
Pre-Filing Clinical Staff Meeting Agenda, July 2, 2009 - Spherusol

 
 
Memo to File: BLA 125354.0  

 

Pre-Filing Clinical Staff Meeting Agenda

July 2, 2009 2:30 PM

 

Attendees: Bridgewater, Jennifer, Daugherty, Jon, Gruber, Marian, Morris, Sheldon, Pratt, Douglas R., Richman, Paul G., Schwartz, Ann, Wieland, Holly.

 

The purpose of this pre-filing meeting was to discuss with upper management several unresolved issues raised by the review team at the June 29, 2009, pre-filing meeting. Reviewers raised two questions that needed guidance from upper management. The two questions were: 1) is the safety database large enough, and 2) what is the appropriate indication?

 

In response to Question #1, Dr. Gruber, Acting Deputy Director, OVRR, asked if changing from -----(b)(4)-------------- in the formulation changed the safety profile. Dr. Richman advised that although there were few safety-related events in the previous preparation, the change to -(b)(4)- was believed to be an improvement to the safety profile. Dr. Gruber agreed that that the sample size of 125 was small, but sufficient for the BLA review to proceed, in particular when considering the large safety base with       --------------(b)(4)------------. She recommended adding a post-marketing monitoring requirement to further evaluate the safety profile.

 

In response to Question #2,the proposed indication, “assessing delayed-type hypersensitivity to Coccidiodes immitis” was allowed at the August 27, 2008, pre-BLA meeting with the caveat that “…further discussions, which could include an advisory committee regarding the clinical criteria needed to support an indication for this product, may be necessary”. After discussion with the review team, Dr. Gruber advised that this product has a ------------------------------------(b)(4)------------------------. Therefore, the acceptance and potential licensure of the proposed indication (or any other indication) would be a review issue and not a filing issue.

 

Submitted by

Holly Wieland, RN, MPH

Center for Biologics Evaluation and Review

Office of Vaccine Research and Review

Division of Vaccines and Related Product Applications