TL;DR
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Final analyses from the ORIGIN and VISIONARY phase III trials found that atacicept and sibeprenlimab slowed loss of kidney function in adults with IgA nephropathy compared with placebo. The results address a condition of the drugs’ accelerated FDA approvals; the sponsors plan to use the findings to seek traditional approval.
Final analyses of two phase III trials found that atacicept and sibeprenlimab slowed kidney-function decline in adults with IgA nephropathy compared with placebo, meeting the kidney-outcome requirement tied to their accelerated U.S. approvals. The findings, presented at the American Society of Nephrology’s Kidney Week meeting on October 24, 2026, could support applications for traditional FDA approval.
In the 431-person ORIGIN trial, patients received weekly atacicept injections or placebo. At week 52, mean estimated glomerular filtration rate (eGFR), a measure of kidney function, changed by -0.11 mL/min/1.73 m² with atacicept and -5.69 with placebo. Over 104 weeks, the annualized eGFR slope was -0.60 per year in the atacicept group and -5.60 per year in the placebo group, a between-group difference of 5.00 mL/min/1.73 m² per year.
A composite measure of kidney-disease progression through week 104 occurred in 5.1% of atacicept recipients and 17.8% of placebo recipients. The trial’s definition included sustained eGFR decline, very low eGFR, long-term dialysis, transplant or death. The researchers reported a 76% lower relative risk with atacicept. No atacicept-treated patients reached dialysis, received a transplant or died; seven placebo patients experienced one of those outcomes.
In the 510-person VISIONARY trial, participants received sibeprenlimab every four weeks or placebo. The annualized eGFR slope over 104 weeks was 0.3 mL/min/1.73 m² per year with sibeprenlimab and -4.2 with placebo. The adjusted treatment difference in eGFR change from baseline to 24 months was 9.2 mL/min/1.73 m². A composite kidney endpoint occurred in one patient receiving sibeprenlimab and 28 receiving placebo. The investigators reported a 97% lower relative risk, while noting that the estimate came from few events.
Both trials were published simultaneously in the New England Journal of Medicine. The drugs had received accelerated FDA approval based on earlier findings showing reduced proteinuria, or protein in urine. The final kidney-function analyses were required to confirm clinical benefit for continued approval.
Kidney Outcomes Behind FDA Approval
The results address a central limitation of accelerated approval: whether an improvement in an earlier marker, such as proteinuria, is accompanied by evidence of slower loss of kidney function. In these trials, the placebo groups had declining eGFR over two years, while the treatment groups had substantially less decline on the reported measures. That difference matters for a disease that can progress over time and may lead to kidney failure.
The trials do not establish that either medicine prevents kidney failure for every patient, and their results should not be read as a direct comparison between the drugs. They were tested in separate studies with different endpoint definitions and follow-up measures. The findings instead add longer-term kidney-function evidence for each treatment against its own placebo group.
Jonathan Barratt of the University of Leicester said treatment should aim to bring the rate of kidney-function loss below 1 mL/min/1.73 m² per year, the target he associated with the 2025 KDIGO guidelines and the normal physiological rate of decline. The trial averages offer evidence relevant to that goal, but individual outcomes can vary.
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How the Two Trials Differ
Atacicept is a TACI-Fc fusion protein that targets BAFF and APRIL, two immune-system signaling proteins. In ORIGIN, 431 adults with biopsy-confirmed IgA nephropathy were randomized to 150 mg weekly by injection or placebo. Adverse events were reported in 74.8% of the atacicept group and 78.0% of the placebo group; serious adverse events occurred in 7.0% and 15.4%, respectively. One patient in the placebo group died.
Sibeprenlimab is an antibody that selectively inhibits APRIL, with the aim of reducing IgA and galactose-deficient IgA1 levels. VISIONARY randomized 510 patients to 400 mg every four weeks or placebo. Researchers said safety findings at 24 months were consistent with the interim analysis. Overall adverse events, including infections, occurred at similar rates in the two groups, and no deaths were reported.
Because the trials used different composite kidney endpoints, their event counts and relative-risk estimates are not directly interchangeable. Both compared treatment with placebo, and the trial findings were reported by their respective investigators at the same kidney meeting.
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What Approval Still Depends On
The reported trial findings do not themselves constitute traditional FDA approval. The source report said the ORIGIN findings would be submitted to the FDA to support full approval, while Otsuka Pharmaceutical said the VISIONARY findings had been submitted for traditional approval. The FDA’s review timing and decisions were not provided.
The data also do not show how long the effects will persist beyond the 104-week trial period, or how treatment will perform across broader groups in routine care. The kidney endpoints differed between studies, and the VISIONARY relative-risk estimate was based on one event in the treatment group versus 28 in the placebo group. Longer follow-up and regulatory review will help clarify the implications.
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FDA Review and Longer Follow-Up
The next regulatory milestone is FDA review of the final trial evidence in applications for traditional approval. The report said atacicept findings would be submitted for that purpose and that Otsuka had submitted sibeprenlimab’s findings. No FDA decision date was stated.
Investigators and regulators will also be able to assess additional safety and kidney-outcome information as follow-up continues. Until the FDA rules, the reported results remain clinical-trial evidence supporting the applications, not confirmation that traditional approval has been granted.
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Key Questions
What did the final trials find?
The ORIGIN and VISIONARY analyses found slower eGFR decline with atacicept and sibeprenlimab, respectively, than with placebo over the reported follow-up. The studies also reported fewer composite kidney events in their treatment groups.
Are these drugs now fully approved by the FDA?
No traditional FDA approval was reported. Both drugs had received accelerated approval based on proteinuria findings, and the final kidney-outcome data are intended to support applications for traditional approval.
Can the two medicines be compared directly?
Not from these results alone. Atacicept and sibeprenlimab were studied in separate trials with different endpoint definitions, so their figures do not provide a head-to-head comparison.
What remains unknown?
The FDA’s decision and review timeline were not given. The report also does not establish how well the effects last beyond 104 weeks or how outcomes will compare in broader routine-care populations.
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