Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)
Shots:
- The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026
- Trial assessed atrasentan (0.75mg, PO, QD) + RAS inhibitor, unless intolerable, vs PBO in mentioned pts (n=340) for ~132wks. 64 pts on SGLT2 inhibitor dose for over 12wks. were also recruited (exploratory arm)
- Trial showed 36.1% proteinuria reduction as early as 6wks., sustained through Wk. 36 (1EP), with UPCR benefit consistent across subgroups of main cohort & in the exploratory arm (37.4% reduction in UPCR)
Ref: Novartis | Image: Novartis
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
