After the FDA approved Otsuka’s anti-APRIL antibody sibeprenlimab to alleviate the urine protein level in the IgA nephropathy patient group, this approved drug will be commercialised under the brand name ‘Voyxact’. This regulatory relief will make this drug the first ever approved and accelerated APRIL-inhibited antibody.
For this exciting news, one of the analysts at Gugenheim Partners spoke about specific empowering elements of Voyxact’s label, as it is very effective for the patients who have a high risk of disease progression. This is a sign that conspicuously skips the common qualifiers like the rapid progression and high risk visible for different IgAN drugs that have received the fastest approvals.
Analyst added, “Voyxact is not dependent on the baseline proteinuria of 1.5 g/day to be claimed as the certified one for the therapy, unlike with various IgAN therapies in the market. The missed qualifiers by the Voyxact should contribute to the wide commercial uptake.”
The FDA’s approval was supported by the provided interim data from Otsuka’s ongoing Phase 3 VISIONARY study, which includes 510 adult patients with IgAN on standard therapy. Voyxact was consumable once every four weeks and has been differentiated against a placebo. The results highlighted that the treatment, along with the APRIL blocker, tends to mitigate proteinuria by around 51% after a total of nine months of treatment.
It’s an impact that was highly statistically noteworthy. The Voyxact’s approval application depends on the use of proteinuria as a surrogate (supporting) marker for disease progression to kidney failure. Still, the drug’s consistent and quick approval will rely on the validation standard of its clinical advantage. The VISIONARY will deliver these data in an approximate glomerular filtration rate form by early 2026.
After the FDA’s approval on Tuesday, Otsuka became more confident and focused on the other drug development (studies). Otsuka is preparing and polishing itself to enter the IgAN space. This also involves Vera Therapeutics, which was seen touting around 46% of proteinuria reduction for atacicept, a drug candidate and further confirmed the plans to go ahead with the FDA regarding filing.
Alongside Vertex Pharmaceuticals, which is initiating its testing process of povetacicept, a kidney drug and inhibitor of APRIL and BAFF cytokines in the PHASE 3 RAINIER study, has also kept an eye on the fastest FDA pathway.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
