ASN Glomerular Disease Advisory Group Meets with FDA

Dialogue between members of the U.S. Food and Drug Administration and ASN’s Glomerular Disease Advisory Group continued at the recent National Institute of Diabetes and Digestive and Kidney Diseases–sponsored symposium Glomerular Disease: Pathophysiology, Biomarkers, and Registries for Facilitating Translational Research. The discussion focused on possible end points to support the approval of new treatments for glomerular disease.
Challenges associated with establishing proteinuria as a surrogate end point (a biomarker intended to substitute for a clinical efficacy end point) in drug trials for glomerular diseases were identified. Both groups agreed that future discussions should focus on the data supporting proteinuria as a surrogate within the context of a specific glomerular disease.
Patient-reported outcome measures were recognized as another important approach for establishing a drug’s efficacy and an area that required further exploration and discussion. It was also agreed that a number of disease-specific and thematically-focused “white papers” should be published as a joint venture. These papers will address the next steps in defining optimal end points for the approval of drugs to treat glomerular diseases.