Atacicept

iStock, Daria Bulgakova Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy. The FDA has granted accelerated approval to Otsuka’s anti-APRIL antibody sibeprenlimab to reduce urine protein levels in patients with IgA nephropathy. The drug will carry the brand name Voyxact. Clearing this regulatory hurdle makes Voyxact the first and so far only approved APRIL-inhibiting antibody, Otsuka said in its news release . Reacting to the news in a note on Tuesday evening, analysts at Gugenheim Partners zeroed in on certain “encouraging elements” of Voyxact’s label. In particular, the firm noted that Voyxact is meant for patients who are at risk of disease progression—an indication that conspicuously omits typical qualifiers such as “high risk” and “rapid progression” seen for other IgAN drugs given accelerated approvals. In addition, and “crucially,” according to the analysts, Voyxact does not require baseline proteinuria of 1.5 g/day as a qualification for the therapy, unlike with other available IgAN therapies. Voyxact’s lack of such qualifiers “should support broad commercial uptake,” the analysts wrote. Voyxact also comes as a prefilled syringe and is designed to be self-administered, offering convenience that bodes “positively” for Otsuka and the drug, they added. Otsuka has yet to provide guidance on Voyxact’s pricing or a timeline for its launch in the U.S. The FDA’s approval was backed by interim data from the ongoing Phase III VISIONARY study, which involves 510 adult IgAN patients on standard therapy. Voyxact was given once every four weeks and is being compared against placebo. Results showed that treatment with the APRIL blocker reduced proteinuria by 51% after nine months of treatment, an effect that was highly statistically significant. Voyxact’s approval application relies on the use of proteinuria as a surrogate marker for disease progression to kidney failure, but the drug’s continued approval will depend on the validation of its clinical benefit. VISIONARY will also provide these data, in the form of estimated glomerular filtration rates, expected in early 2026. Immunology and inflammation Novartis, Vertex, More Optimizing Shots on Multiple Goals in Lucrative I&I Space With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive. November 12, 2025 · 6 min read · Heather McKenzie With Tuesday’s approval, Otsuka grabs an edge on other drugmakers seeking to enter the IgAN space. These include Vera Therapeutics, which earlier this month touted a 46% proteinuria reduction for its drug candidate atacicept and announced plans to approach the FDA with a filing. Also in the running is Vertex Pharmaceuticals, which is testing its kidney drug povetacicept—an inhibitor of both the BAFF and APRIL cytokines—in the Phase III RAINIER study, with an eye toward accelerated approval. The company is targeting an FDA nod by the end of 2026.

Otsuka secured FDA accelerated approval for its antibody drug in a disease that impacts the kidneys’ ability to filter waste. The Japanese drugmaker said late Tuesday the agency greenlit sibeprenlimab for IgA nephropathy (IgAN). The decision was based on data from a Phase 3 trial called VISIONARY in which sibeprenlimab reduced levels of protein in the urine, also known as proteinuria, by just over half versus placebo. Proteinuria is a biomarker of kidney function. Otsuka obtained the rights to sibeprenlimab during its $430 million acquisition of Visterra in 2018. The drug will be marketed as Voyxact. Pricing information wasn’t immediately available. Voyxact is the first drug of its class to clinch an approval in IgAN. It works by blocking a ligand called APRIL which is believed to drive the production of the abnormal IgA protein that builds up in the kidneys. These protein deposits damage the delicate filters that run through the kidneys, causing tissue damage and scarring. “We’re really hoping that in addition to improving symptoms, [Voyxact] will actually improve long-term kidney outcomes and has the potential for disease modification,” Otsuka chief medical officer John Kraus told Endpoints News in an interview prior to the approval. Vera Therapeutics is also advancing an APRIL-directed drug for IgAN called atacicept. The biotech has shared Phase 3 data and filed its drug for accelerated approval. Atacicept also targets a different family of ligands called BAFF. But Voyxact is arguably the more convenient option thanks to its once-monthly injection schedule, compared with atacicept’s once-weekly regimen. Meanwhile, Vertex is also advancing a dual APRIL/BAFF inhibitor called povetacicept that it says has “pipeline-in-a-product” potential. The IgAN market is already highly competitive. Novartis’ factor B inhibitor Fabhalta won accelerated approval for IgAN in August 2024, and cleared a confirmatory trial last month. In April, the Swiss company’s endothelin A receptor antagonist Vanrafia also clinched an accelerated approval for IgAN. Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo have been on the market for some years. All four of the drugs are taken orally, which patients generally tend to prefer over injections. How well Voyxact does commercially could also depend on estimated glomerular filtration rate data from the VISIONARY study, which is expected in early 2026. This is a more robust measure of kidney function compared with proteinuria. The company says that data is intended to support traditional approval.