Jul 16, 2026
  • 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

East Hanover, July 16, 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 approval
The 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 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.

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.

FABHALTA Indication

FABHALTA is a prescription medicine used to slow kidney function decline in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.

It is not known if FABHALTA is safe and effective in children with IgAN.

FABHALTA Important Safety Information

FABHALTA is a medicine that affects part of the immune system and may lower one’s ability to fight infections. FABHALTA increases the chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or cause death if not recognized and treated early. Patients must complete or update vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before the first dose of FABHALTA. If patients have not completed vaccinations and FABHALTA must be started right away, they should receive the required vaccinations as soon as possible. If patients have not been vaccinated and FABHALTA must be started right away, they should also receive antibiotics to take for as long as their health care provider tells them. If patients have been vaccinated against these bacteria in the past, they might need additional vaccinations before starting FABHALTA. Their health care provider will decide if they need additional vaccinations. Vaccines do not prevent all infections caused by encapsulated bacteria. Patients should tell their health care provider or get emergency medical care right away if they get any of these signs and symptoms of a serious infection: fever with or without shivers or chills; fever with chest pain and cough; fever with high heart rate; headache and fever; confusion; clammy skin; fever and rash; fever with breathlessness or fast breathing; headache with nausea or vomiting; headache with stiff neck or stiff back; body aches with flu-like symptoms; or eyes sensitive to light. Health care providers will give their patients a Patient Safety Card about the risk of serious infections. Patients must carry it with them at all times during treatment and for 2 weeks after the last dose of FABHALTA. The risk of serious infections may continue for a few weeks after their last dose of FABHALTA. It is important for patients to show this card to any health care provider who treats them. This will help health care providers diagnose and treat patients quickly.

FABHALTA is only available through a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before patients can take FABHALTA, their health care provider must enroll in the FABHALTA REMS program, counsel their patients about the risk of serious infections caused by certain bacteria, give their patients written information about the symptoms of serious infections, make sure that their patients are vaccinated against serious infections caused by encapsulated bacteria, make sure that their patients receive antibiotics if they need to start FABHALTA right away and are not up-to-date on vaccinations, as well as give patients a Patient Safety Card about the risk of serious infections.

Patients should not take FABHALTA if they are allergic to FABHALTA or any of the ingredients in FABHALTA. Patients should not take FABHALTA if they have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b, when starting FABHALTA.

Before taking FABHALTA, patients should tell their health care provider about all their medical conditions, including if they have an infection or fever, have liver problems, are pregnant or plan to become pregnant (it is not known if FABHALTA will harm an unborn baby), or are breastfeeding or plan to breastfeed as it is not known if FABHALTA passes into breast milk. Patients should not breastfeed during treatment and for 5 days after the final dose of FABHALTA.

Patients should tell their health care provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FABHALTA with certain other medicines may affect the way FABHALTA works and may cause side effects. Patients should know the medicines they take and the vaccines they receive. Patients should keep a list of them to show their health care provider and pharmacist when they get a new medicine.

FABHALTA may cause serious side effects, including those mentioned above as well as increased cholesterol and triglyceride (lipid) levels in the blood. Health care providers will do blood tests to check patients’ cholesterol and triglycerides during treatment with FABHALTA. Health care providers may start patients on medicine to lower cholesterol if needed.

The most common side effects of FABHALTA in adults include: headache; nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis); diarrhea; feeling dizzy; pain in the stomach (abdomen); infections (bacterial and viral); nausea; and rash.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

VANRAFIA Indication

VANRAFIA is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly. It is not known if VANRAFIA is safe and effective in children.

VANRAFIA is approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether VANRAFIA slows decline in kidney function.

VANRAFIA Important Safety Information

VANRAFIA can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking VANRAFIA, become pregnant during treatment, or for 2 weeks after stopping treatment. Females who can become pregnant should have a negative pregnancy test before starting VANRAFIA.

Patients who can become pregnant are those who have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that patients have not had a menstrual period for at least 12 months for natural reasons, or that patients have had their ovaries removed. Patients who cannot become pregnant are those who have not yet entered puberty, or do not have a uterus, or have gone through menopause. Females who can become pregnant should use effective birth control before starting treatment with VANRAFIA, during treatment with VANRAFIA and for 2 weeks after stopping VANRAFIA because the medicine may still be in their body. Patients should talk to their health care provider or gynecologist (a health care provider who specializes in reproduction) to find out about options for effective forms of birth control that they may use to prevent pregnancy during treatment with VANRAFIA. If the patient decides that they want to change the form of birth control that they use, they should talk to their health care provider or gynecologist to be sure that they choose another effective form of birth control. Patients should not have unprotected sex. Patients should talk to their health care provider or pharmacist right away if they have unprotected sex or if patients think their birth control has failed. Their health care provider may talk to them about using emergency birth control.

Patients should tell their health care provider right away if they miss a menstrual period or think that they may be pregnant. Patients should not take VANRAFIA if they are pregnant, plan to become pregnant, or become pregnant during treatment with VANRAFIA. VANRAFIA can cause serious birth defects. Patients should not take VANRAFIA if they are allergic to atrasentan or any of the ingredients in VANRAFIA.

Before taking VANRAFIA, patients should tell their health care provider about all their medical conditions, including if they have liver problems, are pregnant or plan to become pregnant during VANRAFIA treatment (VANRAFIA can cause serious birth defects) or if they are breastfeeding or plan to breastfeed. It is not known if VANRAFIA passes into their breast milk. Patients should not breastfeed during treatment with VANRAFIA. Patients should talk to their health care provider about the best way to feed their baby if they take VANRAFIA.

Patients should tell their health care provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VANRAFIA with certain medications may affect the way VANRAFIA, and the other medicine works and may increase their risk for side effects. Patients should not start any new medicine until they check with their health care provider.

VANRAFIA may cause serious side effects, including those mentioned above as well as liver problems, fluid retention and decreased sperm counts. Medicines like VANRAFIA can cause liver problems, including liver failure. VANRAFIA can increase liver enzymes in the patients’ blood. The patients’ healthcare provider will do blood tests to check their liver enzymes before starting treatment and if needed during treatment. The patients’ healthcare provider may temporarily stop or permanently stop treatment with VANRAFIA if their liver enzymes increase or if they develop symptoms of liver problems. Patients should tell their health care provider if they have any of the following symptoms of liver problems while taking VANRAFIA; nausea or vomiting, pain in the upper right stomach, tiredness, loss of appetite, yellowing of their skin or whites of their eyes, dark urine, fever, itching. VANRAFIA can cause their body to hold too much water (fluid retention). Patients should tell their healthcare provider if they develop any unusual weight gain, trouble breathing, or swelling of their ankles or legs during treatment. Their healthcare provider may prescribe other medicines (diuretics) and may temporarily stop VANRAFIA if they develop fluid retention. VANRAFIA may cause decreased sperm counts in males and may affect the ability to father a child. Patients should tell their doctor if being able to have children is important to them.

The most common side effects of VANRAFIA include swelling of the hands, legs, ankles, and feet (peripheral edema) and low red blood cell count (anemia).

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

Disclaimer
This 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 Novartis
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References

  1. FABHALTA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; July 2026.
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. Sim JJ et al. Poster TH-PO615 presented at: ASN Kidney Week 2023; November 2-5, 2023; Philadelphia, PA.
  10. 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
  11. 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.
  12. 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
  13. 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
  14. 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.

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