Novartis Highlights Results from the P-III (ALIGN) Study of Atrasentan for the Treatment of IgA Nephropathy (IgAN) at ERA 2024
Shots:
- The P-III (ALIGN) trial assesses atrasentan’s (0.75mg, oral, QD) safety & efficacy + SoC & RAS inhibitor dose, unless intolerable, vs PBO in IgAN patients (n=340) at risk of progressive kidney function loss. 64 additional patients on a SGLT2 inhibitor dose for over 12wks. are also recruited (exploratory arm)
- The results depicted 36.1% reduced proteinuria at 36wks.; final analysis incl. 2EP of change in eGFR at 136wks. & exploratory arm data are anticipated in 2026 with the US FDA submission for the same in H1’24
- The company will also feature Fabhalta’s 6mos. & 33mos. P-III (APPEAR-C3G) & P-II extension study data, respectively, in C3G; 9mos. P-III (APPLAUSE-IgAN) study data in IgAN; 1yr. P-I/II study data of zigakibart in IgAN & RWE in C3G & aHUS at ERA'24
Ref: Novartis | Image: Novartis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
