- FDA granted accelerated approval for atrasentan for proteinuria reduction in IgA nephropathy (IgAN).
- IgAN is a chronic immune-mediated glomerular disease with considerable heterogeneity in progression and a significant risk of kidney failure.
- Atrasentan reduced proteinuria by 36.1% in adults with IgAN.
- Effects were observed as early as week 6 and were sustained through week 36.
- A generally favorable safety profile was found for atrasentan, although liver enzyme testing is recommended.
- Continued approval depends on further verification of clinical benefit in the ongoing study until 2026.
Source: Novartis