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.
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.
