Fabhalta (iptacopan) for IgA nephropathy
What the FDA decided
The FDA approved Novartis's sNDA for Fabhalta (iptacopan) in IgA nephropathy. Conversion from accelerated to traditional approval under priority review, based on 24-month APPLAUSE-IgAN data showing a 48% slower decline in kidney function. Tarpeyo and Filspari already carried kidney-function claims in IgAN, and Fabhalta now joins them.
Who this decision matters to
IgA nephropathy is the most common primary glomerulonephritis worldwide, caused by abnormal IgA1 antibodies depositing in the kidney's mesangium, activating complement pathways and triggering inflammation that progressively damages the kidneys. While some patients have a benign course, about 1 in 5 people with IgA nephropathy develop kidney failure within 10 years (NIDDK). Six disease-specific therapies, including a gut-targeted steroid and drugs targeting complement, endothelin, and the APRIL/BAFF pathway have reached FDA approval since 2021, most recently Trutakna (atacicept) in July 2026.
Prevalence: About 2 new cases per 100,000 people each year in the U.S., and an estimated 199,000 to 208,000 Americans were living with IgA nephropathy in 2021 (Otsuka-funded study, Clinical Nephrology, 2025). About 1 in 10 kidney biopsies in the U.S. show IgA nephropathy (NIDDK). Significantly more common in East Asian and Pacific Islander populations, with reported incidence up to 4 times higher.. See our full IgA Nephropathy page for current treatments, recruiting trials, and community resources.
About the drug
Fabhalta: selective oral inhibitor of complement factor B, preventing activation of the alternative complement pathway that amplifies kidney inflammation. Our full Fabhalta profile covers how it works, side effects in plain language, and its trial history.
Where IgA Nephropathy treatment stands today
Read our full IgA Nephropathy treatment summary
IgA nephropathy treatment has transformed dramatically, with six disease-specific FDA-approved therapies now available: targeted-release budesonide (Tarpeyo), the endothelin blockers Filspari (sparsentan, which also blocks angiotensin) and Vanrafia (atrasentan), the complement inhibitor Fabhalta (iptacopan), the APRIL inhibitor Voyxact (sibeprenlimab), and, newest, Trutakna (atacicept), approved in July 2026 as the first FDA-approved dual BAFF/APRIL inhibitor. Beyond the approved options, active trials include Biohaven's BHV-1400, a first-in-class degrader that selectively removes the pathogenic Gd-IgA1 antibody and whose pivotal trial is expected to start in the second half of 2026, plus late-stage programs like felzartamab, zigakibart and sefaxersen.
Povetacicept and Ultomiris (ravulizumab) are under FDA review, with decisions expected by the end of 2026. These targeted options represent a genuine shift from generic immunosuppression toward addressing the specific mechanisms of kidney damage.
The IgA Nephropathy Foundation and NephCure maintain current trial databases. If you have persistent protein in your urine above 0.5-1 gram per day despite maximum supportive therapy, you may qualify for trials of emerging therapies, and with multiple approved drugs now available, discussing the full treatment sequence with your nephrologist matters more than ever.
A kidney biopsy is essential for diagnosis and helps predict your individual risk of progression.
The IgA Nephropathy page has every treatment and trial →Meanwhile, 90 IgA Nephropathy trials are recruiting
Whatever the FDA decides here, research on IgA Nephropathy does not stop. A few currently enrolling studies, US sites first:
Earlier-stage drugs Trial Friend tracks for IgA Nephropathy
You'll hear about future FDA decisions and new recruiting trials for IgA Nephropathy. Unsubscribe anytime.
Our coverage
Frequently asked questions
Has the FDA decided on Fabhalta?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: Novartis press release
What was Fabhalta approved for?
The FDA approved Novartis's sNDA for Fabhalta in IgA nephropathy.
What to know: Conversion from accelerated to traditional approval under priority review, based on 24-month APPLAUSE-IgAN data showing a 48% slower decline in kidney function. Tarpeyo and Filspari already carried kidney-function claims in IgAN, and Fabhalta now joins them.
How it works: Selective oral inhibitor of complement factor B, preventing activation of the alternative complement pathway that amplifies kidney inflammation.
More: the Fabhalta drug page explains it in plain language.
Is there already an FDA-approved treatment for IgA Nephropathy?
Yes. Trial Friend's drug list includes 6 FDA-approved drugs for IgA Nephropathy.
Approved: Tarpeyo (budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), Trutakna (atacicept).
Also coming: Felzartamab, Zigakibart, Povetacicept, Sefaxersen, Ultomiris (ravulizumab).
Check: the IgA Nephropathy page also searches FDA drug labels for approved treatments.
What did the Fabhalta trials show?
The Phase 3 APPLAUSE-IgAN trial enrolled approximately 518 patients overall. Over 2 years, kidney function (eGFR) declined 3.0 points a year with iptacopan versus 5.7 on placebo, a 48% slower decline, and the FDA granted traditional approval on July 16, 2026.
More: the Fabhalta drug page has the full trial history and sources.
What are the side effects of Fabhalta?
Fabhalta carries a boxed warning for serious and life-threatening infections caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b. Patients must complete or update vaccinations against these bacteria at least 2 weeks before the first dose, and the drug is only available through a restricted program (the FABHALTA REMS).
More: the Fabhalta drug page lists the warnings in full.
How much will Fabhalta cost?
Trial Friend does not list a price for Fabhalta. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Drugmaker help: Novartis Patient Support.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Fabhalta decision?
The FDA approved Fabhalta for IgA nephropathy on July 16, 2026.
Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Novartis press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.