
Internal Meeting Minutes, November 2, 2009 - Spherusol

 
 
BLA 125354.0  
Internal Meeting Minutes
November 2, 2009 1:00 PM – 3:00 PM WOC 1 CR 300 N

 

Attendees: Paul Richman, Douglas Pratt, Jon Daugherty, Jingyee Kou, Marion Gruber, Sheldon Morris (by phone), Ann Schwartz and Holly Wieland.

 

Purpose: To discuss the clinical indication(s) for the Coccidioidin skin test

 

Discussion:

 

A meeting was held to discuss concerns about the medical relevance of the proposed indication for the product Coccidioides immitis Spherule-Derived Skin Test Antigen. At the pre-BLA meeting held on August 27, 2008, and in the pre-BLA teleconference meeting summary sent to the Applicant on September 16, 2008, CBER agreed to consider that the product be indicated for use in the detection of delayed-type hypersensitivity to Coccidioides immitis indicative of prior exposure to C. immitis. In addition, we also stated that “…further discussions, which could include an advisory committee regarding the clinical criteria needed to support an indication for this product, may be necessary.” No information on the clinical use of the product in any population has been provided by the Applicant. The proposed indication presented in the BLA submission of detection of delayed type hypersensitivity following exposure to C. immitis may be relevant within a clinical setting, but further information from the Applicant is required to make this determination. Without evidence of how the product will be used in a clinical setting, CBER is unable to assess the risks and/or benefits of the use of this product. 

 

Based on a continuing question as to the clinical use of the product in relationship to the proposed indication, CBER will ask the Applicant in the CR letter to provide information on the clinical use of the product. Upon receipt of this information, further discussion may be necessary and additional clinical studies may be required to support the clinical use of the product. 

 