FDA has granted accelerated approval for atrasentan for the reduction of proteinuria in IgAN patients who are at risk of rapid progression, with no need for a Risk Evaluation Mitigation Strategy program. The therapy, indicated for patients with a urine protein-to-creatinine ratio of 1.5 g/g or more, was found to have a generally favorable safety profile, although liver enzyme testing is recommended due to potential hepatotoxicity. A phase III trial revealed that the drug, which is a selective endothelin A receptor antagonist, significantly reduced proteinuria by 36.1% in adults with immunoglobulin A nephropathy (IgAN) as early as week 6 and sustained through week 36. Continued approval depends on further verification of clinical benefit in the ongoing study until 2026.

Source: Novartis