Skip to main content

Glomerular Diseases & Prevalence

Basic Details
Status
Complete
Last Updated
Tuesday, October 15, 2024
Original Posting Date
Health Outcome(s)
glomerular diseases
Purpose
Other Regulatory
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

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.