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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Memorandum(2)- Spherusol

BLA STN 125354
Coccidioides immitis Spherule-Derived Skin Test Antigen, Allermed Laboratories, Inc.
OBE/DE Review for Pharmacovigilance Planning      

 
  
From:  Alexis Mosquera, BSN
Regulatory Reviewer, OBE/DE/TBSB
Through:  
Craig Zinderman, MD, MPH
Acting Chief, TBSB/DE/OBE/CBER
 
Robert P. Wise, MD, MPH
Deputy Division Director, OBE/DE
 
    
        
       
 
Background   
 
OBE/DE has completed an initial review of BLA STN 125354 for Coccidioides immitis Spherule-Derived Skin Test Antigen from Allermed Laboratories Inc. (hereafter referred to as Coccidioidin SD). The purpose of the review is to identify potential safety issues that might need to be addressed in a Pharmacovigilance Plan. Note: The following review contains statements taken directly and/or indirectly from the sponsor’s BLA Summary, section A, pp. 1-2 . Paragraphs in italics were taken directly from the BLA Summary section A, p.1.
 
 
Disease
Coccidioidomycosis is a fungus infection which is acquired by the inhalation of the spores of the fungus C.immitis. The disease is usually a self-limiting pulmonary infection characterized by flu-like symptoms. In a small percentage of individuals, the primary pulmonary infection may progress to pneumonia, or disseminate to other parts of the body, including the skin, bones and central nervous system. In some cases the outcome is fatal.
 
Estimates indicate that four million people live in areas of the U.S. were C.immitis is endemic in the soil. Among naïve persons, the chance of infection is about three percent per year. The longer one resides in an endemic area, the greater risk of contracting the disease. There are approximately 100,000 new infections each year in the U.S.. Most infections occur in Southwestern states of the U.S. (Texas, Southern California, Arizona). The most common symptoms are fatigue, fever, rash, headache, and joint aches. The usual course of the disease in otherwise healthy people is complete recovery within six months. About five percent of patients develop lung cavities and one to two percent develop disease that disseminates to other parts of the body. Meningitis is the most serious and lethal complication of disseminated disease.
 
Product
 
------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
 
According to the sponsor’s BLA Summary (section A, p. 2) Coccidioidin SD is manufactured by diluting ----------------------------------(b)(4)-------------------------------- saline containing 0.4% phenol as preservative. Coccidioidin SD is preserved with 0.4% phenol -----------------------------(b)(4)---------------------------------. The final product contains 12.7 ug/mLof C.immitis antigen.
 
Coccidioidin SD was granted orphan-drug status on December 19, 2007.
 
Filing Issues
 
There are no filing issues in this original BLA submission for DE. However, the BLA submission does not include a pharmacovigilance plan.
 
Review Issues
 
When a new product is marketed, the exposed population may differ from the population studied in clinical trials. Pharmacovigilance plans are designed to identify and describe potential serious safety risks, important missing information, or inadequately studied at-risk populations, and should include routine pharmacovigilance (i.e., compliance with applicable post-market reporting requirements under FDA regulations) and possibly additional post-market safety monitoring activities.
 
The ICH E2E Pharmacovigilance Planning (PVP) Guidance (http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm) indicates that for products with important identified risks, important potential risks, or important missing information, additional actions designed to address these concerns should be considered as part of a pharmacovigilance plan. The pharmacovigilance plan is developed by a product’s sponsor and is specifically focused on detecting new safety risks and/or evaluating already identified safety risks. The sponsor should submit a detailed pharmacovigilance plan in accordance with the E2E PVP guidance.
 
 
Letter Ready Comments
 
Please submit a pharmacovigilance plan for Coccidioidin SD. When a new product is marketed, the exposed population may differ from the population studied in clinical trials. Pharmacovigilance plans are designed to identify and describe potential serious safety risks, important missing information, or inadequately studied at-risk populations, and should include routine pharmacovigilance (i.e., compliance with applicable post-market reporting requirements under FDA regulations) and possibly additional post-market safety monitoring activities.
 
The ICH E2E Pharmacovigilance Planning (PVP) Guidance (http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm) indicates that for products with important identified risks, important potential risks, or important missing information, additional actions designed to address these concerns should be considered as part of a pharmacovigilance plan. The pharmacovigilance plan is developed by a product’s sponsor and is specifically focused on detecting new safety risks and/or evaluating already identified safety risks.  Please submit a detailed pharmacovigilance plan in accordance with the E2E PVP guidance.