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Vaccines, Blood & Biologics

Minutes of Meeting, March 23, 2011 - Spherusol

Meeting ID#:                       BLA 125354

Product Name:                    Coccidioides immitis Spherule-Derived Skin Test Antigen
Sponsor:                             Allermed Laboratories, Inc.
Sponsor Contact:                 H.S. Nielsen, Jr., Ph.D.
Meeting Type:                      Internal
Meeting Date/Time:             March 23, 2011, 3:30 PM
Meeting Format:                  WOC 2 CR 2330 with Teleconferencing available
Meeting Chair/Leader:         Sheldon Morris, Chair
Meeting Recorder:                Holly Wieland

CBER Attendees:                      Jennifer Bridgewater
  Karen Campbell
  Dennis Cato
  Siobhan Cowley
  Jon Daugherty
  Karen Elkins
  Doran Fink
  Amelia Horne                         
  Anthony Hawkins
  Dana Jones
  Jingyee Kou
  Sheldon Morris
  Alexis Mosquera
  Douglas Pratt
  Paul Richman
  Jeff Roberts
  Estelle Russek-Cohen
  Ann Schwartz
  Wellington Sun
  Joseph Temenak
  Deborah Trout
  Holly Wieland
  Craig Zinderman
Brief Background/Development Plan

In the submission dated January 17, 2011, in response to the Type B Meeting held on January 12, 2011, the sponsor has submitted the proposed indication for this product:
"Spherusol is indicated for use as a skin test antigen for the detection of delayed type (IV) cell mediated hypersensitivity following pulmonary infection with C. immitis.”
"Spherusol should not be used to diagnose active disease or disseminated disease caused by C. immitis because it has not been studied for use in diagnosing those conditions."
Purpose of Meeting

The purpose of this meeting is to come to final agreement on the following:
1. Assuming there are no other review issues, can this product be licensed without any further clinical studies?
2. If the answer is 'yes', what will be the specific indication?
3. If additional clinical studies are needed, will they need to be conducted pre-licensure or post-licensure?
Meeting Discussion

The following points were discussed during the meeting.
1. CBER may allow a very narrow indication limiting it to what the sponsor evaluated, that is:
a. In the endemic area, people with a known history of disease tested positive;
b. In a non-endemic area, people with no known history of disease tested negative;
c. In a non-endemic area, testing for cross-reactivity in individuals with histoplasmosis was negative.
2. This product has not been tested on any special populations, such as pregnant women or immunocompromised people. The sponsor will need to do additional clinical trials before those indications could be considered.
3. This action should not be viewed as setting precedent. Rather, one could view this as a special case because ------------------------------------(b)(4)----------------------------------------
Action Items

The review team will continue to work on the language for the indication. The proposed indication and other labeling as it relates to the proposed indication will be addressed in the labeling review and negotiations. Consensus is building that the sponsor may be allowed a very narrow indication such as follows:
Spherusol is a skin test antigen indicated for the detection of delayed type hypersensitivity to C. immitis in healthy individuals with a past history of pulmonary coccidioidomycosis.
Spherusol should not be used to diagnose active disease or disseminated disease caused by C. immitis.
Committee members were requested to prepare to complete the action on this BLA at least 2 to 3 weeks prior to the action due date of July 29, 2011.


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