Novartis IgAN data in The Lancet show clinically meaningful slowing of kidney function decline with Vanrafia® over 2.5 years

Key efficacy results^1,2

^* Week 132 plus a 4-week off-treatment follow-up
^† UPCR at Week 36 assessed using 24-hour urine collection; UPCR at Week 132 assessed using first-morning void samples.
All p values are nominal except for the change from baseline in eGFR at the end of study in the main cohort; all p values are two-sided; eGFR change from baseline is expressed in mL/min/1.73 m²; annualized eGFR slope is expressed in mL/min/1.73 m²/year

“ALIGN reinforces Vanrafia’s potential as a foundational IgAN therapy and our commitment to advancing long-term kidney protection through continued innovation,” said Ruchira Glaser, MD, MS, Global Head, Cardiovascular, Renal and Metabolic Development, Novartis. “Together with our broader portfolio, these data strengthen confidence in an evidence-based approach to managing this progressive disease.”

Safety was consistent with prior studies, with adverse events similar to placebo and no new signals observed^1-4.

Vanrafia received accelerated approval in the U.S. and China for reduction of proteinuria in adults with IgAN in 2025^5,6. Novartis intends to use these data to support submission for traditional approval in 2026.

About IgAN
IgAN is a progressive autoimmune kidney disease, with approximately 25 people per million worldwide newly diagnosed each year^7,8. IgAN is highly debilitating as it leads to inflammation in the small filters of the kidneys, excess protein in urine, and a gradual decline in eGFR⁹. Up to 50% of patients with persistent protein in the urine progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation as part of long-term disease management^8-13.

Furthermore, people living with IgAN often face mental and social challenges^9-12. Supportive care has not addressed the underlying causes of the disease and often fails to slow disease progression, reinforcing the need for more targeted therapies for IgAN^10-15.

About ALIGN^1-4,15
The ALIGN study (NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of Vanrafia vs placebo in patients with IgAN at risk of progressive loss of kidney function. In total, 340 patients with biopsy-proven IgAN with baseline total proteinuria ≥1 g/day despite optimized renin-angiotensin system (RAS) inhibitor treatment were randomized to receive once-daily, oral Vanrafia (0.75 mg) or placebo for approximately 132 weeks. Patients continue receiving a maximally tolerated and stable dose of a RAS inhibitor as supportive care. An additional cohort of 64 patients receiving an SGLT2 inhibitor in addition to RAS inhibitor for at least 12 weeks was also enrolled. The primary efficacy endpoint for the interim analysis (in 270 patients) was change in protein in urine, as measured by 24-hour UPCR from baseline to 36 weeks. The key secondary endpoint for the final analysis is the change from baseline to 136 weeks in kidney function as measured by eGFR. Other secondary efficacy endpoints as well as safety and tolerability are also assessed.

About Vanrafia^® (atrasentan)
Vanrafia (atrasentan) is a potent and highly selective endothelin A (ETA) receptor antagonist, which is part of the endothelin system, a key system involved in the progression of IgAN^3,16-18.

Vanrafia is the first and only selective ETA receptor antagonist approved for primary IgAN, a once-daily, oral treatment and can be seamlessly added to, or used alongside, existing supportive care (e.g. RAS inhibitor with or without SGLT2 inhibitor) without the need for titration^5,6. Vanrafia does not require a Risk Evaluation and Mitigation Strategy (REMS) program. Because some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure, clinicians should obtain liver enzyme testing before initiating Vanrafia and during treatment when clinically indicated. Vanrafia may cause serious birth defects⁵.

Novartis’ commitment to kidney diseases
Building on a legacy of more than 40 years that began in transplant, Novartis is on a mission to empower breakthroughs and transform care in kidney health, starting with kidney conditions that have significant unmet need. Alongside Vanrafia, Novartis is advancing a multi-asset IgAN portfolio that includes Fabhalta^® (iptacopan) and investigational compound zigakibart.

Historically, these conditions have had considerably less funding and research, leading to a treatment landscape largely focused on reactive or end-stage disease management, often with significant physical, emotional, and financial burdens. Our portfolio targets the underlying causes of disease, with an aim to protect kidney health and delay or prevent dialysis and/or transplantation. Our goal is to help patients get back to living life on their terms - whether at work, in school, or with loved ones, and by partnering with patients, advocates, clinicians and policymakers, we aim to raise awareness, accelerate diagnosis, and get patients the right care, sooner.

Disclaimer
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About Novartis
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