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# Novartis Seeks Accelerated OK for IgAN Drug
- URL: https://www.fdaweb.com/novartis-seeks-accelerated-ok-for-igan-drug/
- Published: 2023-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:14:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155671

Novartis says it will seek FDA accelerated approval after reporting favorable data from an interim analysis of the ongoing pivotal Phase 3 ALIGN study (NCT04573478) of atrasentan, an oral endothelin A receptor antagonist (ERA) for treating patients with IgA nephropathy (IgAN).

The interim data show that the study met its primary efficacy endpoint at the 36-week cutoff, according to the company, with atrasentan “demonstrating superiority versus placebo with a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine) in patients with IgAN receiving supportive care (maximally tolerated and stable dose of a renin-angiotensin system \[RAS\] inhibitor).” The safety profile in the study was consistent with previously reported data from the Phase 2 AFFINITY study (IgAN cohort), it says.

Novartis says IgAN is a major cause of chronic kidney disease and kidney failure, and mostly affects younger adults. “Up to 30% of people who have IgAN with persistent higher levels of proteinuria (greater than 1g/day) progress to kidney failure within 10 years,” it says.