FDA approved Novartis' Fabhalta for IgAN to slow kidney function decline. Phase III ALIGN data for Vanrafia showed ~34% slower eGFR decline vs placebo and were published in The Lancet.
FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
New research presented at the ERA Congress found DCCB blood pressure medications were associated with a 33% increased risk of major adverse kidney events in Type 2 diabetes patients also receiving RAS and SGLT2 inhibitors. A separate study revealed that diabetic nephropathy patients exhibit the most severe biochemical disturbances, including markedly elevated glycemic indices and significantly impaired renal function compared to other groups.
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
New AI tools predict diabetic kidney disease from retinal images, flag hemodialysis patients at hospitalization risk, and advance lupus nephritis care. Findings were presented at ARVO 2026 and published in NEJM Catalyst, The Lancet, and the International Journal of Molecular Sciences.
NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
New research shows AI can predict heart disease risk from breast arterial calcification on mammograms, while the BRAIx tool helps assess breast cancer risk. A $16 million U.S. trial, PRISM, will evaluate AI-assisted reading of screening mammograms.
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
