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Glomerular Diseases & Prevalence

    Basic Details
    Last Updated
    Friday, March 1, 2024
    Original Posting Date
    Health Outcome(s)
    glomerular diseases
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    This study was conducted to assist the U.S. Food and Drug Administration (FDA) in reviewing several requests for orphan drug designations by estimating the number of individuals affected by several glomerular diseases in the United States.

    Data from this study suggested glomerular diseases seemed to be rare in the United States. Based on the finding of this study in the FDA’s Sentinel System and Census data projections, numbers of individuals with focal segmental glomerulosclerosis (FSGS), IgA nephropathy (IgAN), membranous nephropathy (MN), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN), crescentic and necrotizing glomerulonephritis (CNGN), lupus nephritis (LN), and nephrotic syndrome (NS) in the United States were all below the 200,000 person threshold for orphan drug designation, for each year from 2016 to 2019.

    Nevertheless, because algorithms used to estimate different glomerular diseases were not validated, estimates are subject to potential case misclassification, which may underestimate or overestimate the true disease prevalence.