All articles tagged with #iga nephropathy
Vertex reported Phase 3 data showing its IgA nephropathy drug reduced a key kidney-disease biomarker by about 50%, in a three-way race with Otsuka and Vera Therapeutics and signaling potential multi-billion-dollar annual sales.
Vertex’s povetacicept demonstrated robust Week 36 interim efficacy in the Phase 3 RAINIER trial for IgA nephropathy, including a 52.0% reduction in 24-hour UPCR (49.8% versus placebo, P<0.0001), a 77.4% reduction in serum Gd-IgA1 (79.3% versus placebo; P<0.0001), and 85.1% hematuria resolution versus 23.4% with placebo (61.7-point difference; P<0.0001). The drug was generally safe and well tolerated. Vertex plans full BLA submission by end of March for potential accelerated FDA approval, with final efficacy analysis scheduled at two years through Week 104.
Otsuka's experimental drug sibeprenlimab showed promising results in reducing toxic protein levels in patients with IgA nephropathy, outperforming Vera Therapeutics in a Phase 3 study, with fewer serious side effects.
Vera Therapeutics announced positive Phase 3 trial results for its kidney disease drug atacicept, which significantly reduced proteinuria in patients with IgA nephropathy, supporting a potential FDA submission later this year.
23-year-old Harris Cannady is in need of a kidney transplant due to a rare auto-immune disorder. His family is seeking a living donor and encouraging others to get tested to see if they are a match. The process has been challenging, but they remain hopeful and are leaning on their faith. The story also highlights the importance of organ donation and the impact it can have on saving lives.
Novartis has announced positive results from the interim analysis of its Phase III ALIGN study, which is evaluating the efficacy of atrasentan, an oral endothelin A receptor antagonist, in patients with IgA nephropathy (IgAN). The study met its primary endpoint, demonstrating superiority of atrasentan over placebo in reducing proteinuria (protein in urine) in patients with IgAN. The safety profile of atrasentan was consistent with previous data. Novartis plans to submit an application for accelerated approval based on these results, with the final readout of the study expected in the first quarter of 2026. IgAN is a progressive kidney disease that affects mostly young adults and is a major cause of chronic kidney disease and kidney failure worldwide. Novartis is developing three therapies for IgAN to address unmet needs in the treatment of the disease.