By SPC Staff
The FDA granted accelerated approval to atrasentan (Vanrafia, Novartis) for proteinuria reduction in primary immunoglobulin A nephropathy (IgAN).
Atrasentan is a once-daily oral treatment that can be added to supportive care for adults at risk for rapid disease progression (urine protein-to-creatinine ratio [UPCR] ≥1.5 g/g1).
The accelerated approval was based on an interim analysis of the ongoing phase 3, double-blind, placebo-controlled ALIGN study (ClinicalTrials.gov