Zigakibart

Fabhalta slowed eGFR decline by 48% vs placebo over two years, demonstrating kidney function preservation1 Clinically meaningful improvements of protein in urine observed as early as two weeks, with sustained reduction over treatment period1 Fabhalta targets the alternative complement pathway; activation is a key driver of inflammation associated with IgAN2-4 Basel, July 17, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression1. Fabhalta, a first-in-class complement inhibitor, received approval under a priority review designation after an initial FDA accelerated approval in August 2024 for the reduction of proteinuria in primary IgAN1.“IgAN is a chronic, immune-mediated disease leading to kidney failure that can have a severe impact on patients’ lives,” said Dana Rizk, M.D., Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham and APPLAUSE-IgAN Steering Committee Member. “The ability to significantly slow kidney function decline is a critical treatment goal. This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health.”Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN, one of the most common autoimmune kidney diseases5. Up to 50 percent of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis and/or kidney transplantation, placing a significant burden on patients6-10.“This milestone is a moment of great hope for the IgAN community,” said Bonnie Schneider, Director and Co-Founder, IgA Nephropathy Foundation. “For patients and families impacted by this progressive disease, knowing that Fabhalta can help preserve kidney function brings renewed confidence and optimism for the future of the IgAN treatment landscape.”Data supporting approvalThe approval of Fabhalta was based on data from the Phase III APPLAUSE-IgAN study. Results demonstrated statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years, with Fabhalta showing an annualized mean change from baseline in eGFR of -3.0 mL/min/1.73 m2/yr compared with -5.7 mL/min/1.73 m2/yr for placebo1. Fabhalta consistently outperformed placebo across key kidney outcomes1.The APPLAUSE-IgAN study showed that Fabhalta has a favorable safety profile, consistent with previously reported data1. The most common adverse events with Fabhalta in patients with IgAN were abdominal pain, dizziness and nausea1. Fabhalta may increase the risk of serious infections caused by encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy (REMS) program requiring appropriate vaccinations prior to treatment1.Transforming care in kidney disease“Today’s approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression, an outcome that matters deeply to patients at risk of long-term kidney damage,” said Victor Bultó, President, US, Novartis. “This milestone underscores the importance of continued innovation for people living with IgAN and our commitment to addressing the underlying drivers of disease.”As each person’s IgAN journey is unique, access to effective, targeted therapies with different mechanisms of action can help physicians select the most appropriate treatment for their patients10-13. Alongside Fabhalta, Novartis is supporting this community through its growing IgAN portfolio, which includes Vanrafia® (atrasentan) and investigational compound zigakibart1,14. Novartis is committed to helping IgAN patients access Fabhalta through a variety of support programs, with nearly 100 percent of US patients paying $10 or less per month.About Fabhalta® (iptacopan)Fabhalta (iptacopan) is an oral Factor B inhibitor designed to selectively target the alternative complement pathway, one of several key drivers of glomerular inflammation and kidney damage in IgAN2-4. By inhibiting Factor B, Fabhalta aims to reduce ongoing complement-mediated injury and slow disease progression. Fabhalta has received regulatory approvals in multiple complement-mediated diseases, including IgAN, and is being evaluated across a range of rare kidney conditions.Novartis’ commitment to kidney diseasesBuilding 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.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.DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.References FABHALTA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; July 2026. Rizk DV, Maillard N, Julian BA, et al. The emerging role of complement proteins as a target for therapy of IgA nephropathy. Front Immunol. 2019;10:504. doi:10.3389/fimmu.2019.00504 Perkovic V, Barratt J, Rovin B, et al. Alternative complement pathway inhibition with iptacopan in IgA nephropathy. N Engl J Med. 2025;392:531–543. doi:10.1056/NEJMoa2410316 Chiu YL, Lin WC, Shu KH, et al. Alternative complement pathway is activated and associated with galactose-deficient IgA(1) antibody in IgA nephropathy patients. Front Immunol. 2021;12:638309. doi:10.3389/fimmu.2021.638309 Zhang H, Rizk DV, Perkovic V, et al. Results of a randomized double-blind placebo-controlled phase 2 study propose iptacopan as an alternative complement pathway inhibitor for IgA nephropathy. Kidney Int. 2024;105(1):189-199. doi:10.1016/j.kint.2023.09.027 Xie J, Kiryluk K, Wang W, et al. Predicting progression of IgA nephropathy: new clinical progression risk score. PLoS One. 2012;7(6):e38904. doi:10.1371/journal.pone.0038904 Pitcher D, Braddon F, Hendry B, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.0000000000000135 Hastings MC, Bursac Z, Julian BA, et al. Life expectancy for patients from the southeastern United States with IgA nephropathy. Kidney Int Rep. 2017;3(1):99-104. doi:10.1016/j.ekir.2017.08.008 Sim JJ et al. Poster TH-PO615 presented at: ASN Kidney Week 2023; November 2-5, 2023; Philadelphia, PA. Rovin BH, Barratt J, Cook HT, et al. KDIGO 2025 clinical practice guideline for the management of immunoglobulin A nephropathy (IgAN) and immunoglobulin A vasculitis (IgAV). Kidney Int. 2025;108(4):S1-S71. doi:10.1016/j.kint.2025.04.004 Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An update on the pathogenesis and treatment of IgA nephropathy. Kidney Int. 2012;81(9):833-843. Lim RS, Yeo SC, Barratt J, Rizk DV. An update on current therapeutic options in IgA nephropathy. J Clin Med. 2024;13(4):947. doi:10.3390/jcm13040947 Glassock RJ. An expert opinion on current and future treatment approaches in IgA nephropathy. Adv Ther. 2025;42(6):2545-2558. doi:10.1007/s12325-025-03187-7 ClinicalTrials.gov. A study of BION-1301 in adults with IgA nephropathy. Identifier NCT05852938. Available at: https://clinicaltrials.gov/ct2/show/NCT05852938. Accessed June 2026. # # # Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

Twelve-month eGFR data from the Phase III VISIONARY trial of sibeprenlimab (Voyxact) in IgA nephropathy show that Otsuka’s anti-APRIL monoclonal antibody stabilized kidney function compared to placebo. The result is likely to support sibeprenlimab‘s conversion of its existing accelerated approval based on proteinuria reduction, since demonstrating eGFR preservation is the confirmatory evidence needed for full FDA approval in IgA nephropathy. The pre-specified interim analysis enrolled 320 adults with primary IgAN at risk of disease progression. At 12 months, sibeprenlimab-treated patients showed a mean eGFR change from baseline of +0.7 mL/min/1.73 m² (95% CI, –0.9 to 2.3), compared with –4.8 mL/min/1.73 m² (95% CI, –6.3 to –3.3) in the placebo arm — a treatment effect of 5.5 mL/min/1.73 m² (95% CI, 3.4 to 7.6). The annualized eGFR slope showed –3.0 mL/min/1.73 m²/year with sibeprenlimab versus –7.6 mL/min/1.73 m²/year with placebo, a treatment effect of 4.6 mL/min/1.73 m²/year. The sibeprenlimab eGFR change from baseline met the KDIGO treatment goal of limiting annual kidney function decline to below 1 mL/min/1.73 m²/year. Safety was consistent with prior data; infections (49% vs. 45%) and injection site reactions (24% vs. 23%) were the most common adverse events, with the majority mild or moderate. Otsuka has initiated a rolling supplemental Biologics License Application (sBLA) submission to the US FDA for traditional approval based on the 24-month eGFR endpoint data, which remain pending. Sibeprenlimab selectively inhibits APRIL, blocking upstream B-cell-driven production of pathogenic galactose-deficient IgA1 without depleting B cells. The IgAN landscape now includes multiple approved agents with distinct mechanisms: Novartis’ Fabhalta (iptacopan), an oral complement factor B inhibitor, reported a 49.3% slowing of eGFR slope decline over two years in the APPLAUSE-IgAN Phase III trial and has a priority review filing pending traditional approval; Vera Therapeutics’ atacicept, a dual BAFF/APRIL inhibitor, has a PDUFA date of July 7, 2026 for accelerated approval. Vertex Pharmaceuticals’ povetacicept, a dual BAFF/APRIL TACI-Fc fusion protein, also has a BLA under rolling review. Cross-trial comparisons are limited by differences in patient populations, background therapy, and follow-up duration. The VISIONARY 24-month final analysis, which serves as the primary confirmatory endpoint for Otsuka’s traditional approval submission, will be the next key data readout. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.