Nephrology – BiotechReality – Information Intelligence System for Biopharma

Quick Summary Positive Kidney Function Impact: Vanrafia (atrasentan) demonstrated a significant slowing of kidney function decline in adults with IgA nephropathy (IgAN). Key eGFR Findings: At Week 136 (4 weeks post-treatment), there was a 2.39 mL/min/1.73m² positive difference in eGFR compared to placebo. At Week 132 (end of treatment), the difference was 2.59 mL/min/1.73m². Broad Efficacy: Results favored Vanrafia across multiple timepoints and were consistent even in patients already using SGLT2 inhibitors. Long-Term Data: The ALIGN study provides the longest follow-up data (136 weeks) currently available for any pivotal Phase III IgAN study. Safety Profile: The treatment was well-tolerated, with safety results remaining consistent with previous studies. Regulatory Status: * Currently has accelerated approval in the U.S. and China (granted in 2025) for proteinuria reduction. Novartis plans to file for traditional approval in 2026 based on these new eGFR results. Mechanism of Action: Vanrafia is a once-daily, oral, highly selective endothelin A (ETA) receptor antagonist that targets a key driver of IgAN progression. Novartis today announced compelling final results from its pivotal Phase III ALIGN study, demonstrating that Vanrafia® (atrasentan) significantly slows the decline of kidney function in adults with IgA nephropathy (IgAN). The data reinforce Vanrafia's potential as a foundational therapy for this progressive autoimmune kidney disease. The ALIGN study, which represents the longest follow-up period in pivotal Phase III studies for IgAN, showed a favorable difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate (eGFR) change from baseline versus placebo (2-sided p 0.057) at Week 136, four weeks after the completion of study treatment. Progressive and complex diseases such as IgAN present an urgent need for medicines that can target the different drivers of the disease. Vanrafia can be seamlessly integrated into patients’ existing treatment plans, with a consistent safety profile, We are pleased with today’s Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline. Ruchira Glaser Clinically meaningful results were consistently observed with Vanrafia compared to placebo across multiple timepoints and measures of kidney function. Notably, at the end of study treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m2 (nominal 2-sided p 0.039). These positive outcomes were also evident in a prespecified exploratory group of patients who were additionally receiving sodium-glucose co-transporter-2 (SGLT2) inhibitors, underscoring Vanrafia’s compatibility with existing supportive care. The safety profile of Vanrafia in the ALIGN study was consistent with previous findings. IgAN is a debilitating autoimmune kidney disease affecting approximately 25 million people globally each year. It leads to glomerular inflammation, proteinuria, and a gradual decline in eGFR, with up to 50% of patients progressing to kidney failure within 10 to 20 years. Current supportive care often fails to address the underlying causes or significantly slow disease progression, highlighting the critical need for more targeted therapies. Read More: Novartis Ianalumab Clinches FDA Breakthrough Status, Aiming to Be First Targeted Treatment for Sjögren’s Disease Vanrafia (atrasentan) is a potent and highly selective endothelin A (ETA) receptor antagonist, targeting a key system involved in IgAN progression. It is the first and only selective ETA receptor antagonist approved for primary IgAN, offering a once-daily, oral treatment. Vanrafia can be seamlessly added to or used alongside existing supportive care (e.g., renin-angiotensin system (RAS) inhibitor with or without SGLT2 inhibitor) without the need for titration and does not require a Risk Evaluation and Mitigation Strategy (REMS) program. Clinicians should obtain liver enzyme testing before initiating Vanrafia and during treatment when clinically indicated, as some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure. Vanrafia may cause serious birth defects. What are the latest results for Vanrafia (atrasentan) in IgA nephropathy?As of February 13, 2026, Novartis has released final Phase III ALIGN study results demonstrating that Vanrafia® (atrasentan) significantly slows the decline of kidney function in adults with IgA nephropathy (IgAN). About IgA Nephropathy (IgAN) IgA nephropathy is a chronic, progressive autoimmune kidney disease characterized by the buildup of immune complexes containing immunoglobulin A (IgA) in the glomeruli of the kidneys. This leads to inflammation and damage, resulting in proteinuria, hematuria, and a progressive decline in kidney function. Many patients eventually develop end-stage kidney disease, requiring dialysis or kidney transplantation. The disease significantly impacts patients' quality of life, presenting mental, social, and economic challenges. About Vanrafia® (atrasentan) Vanrafia (atrasentan) is a highly selective endothelin A (ETA) receptor antagonist. The endothelin system plays a crucial role in the pathogenesis and progression of IgAN through various mechanisms, including vasoconstriction, inflammation, and fibrosis. By selectively blocking the ETA receptor, Vanrafia aims to mitigate these harmful effects and slow disease progression. Information: Novartis Last Modified:

Tag: Nephrology

Novartis Vanrafia® Phase III Data Show Significant Slowing of Kidney Function Decline in IgA Nephropathy Patients

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