Otsuka Pharmaceuticals recently announced that the FDA has accepted for review the biologics licence application (BLA) for sibeprenlimab. Sibeprenlimab acts as an a proliferation-inducing ligand (APRIL) inhibitor in development for immunoglobulin A (IgA) nephropathy (IgAN). This followed sibeprenlimab’s 2024 FDA breakthrough designation for the same indication. The BLA was supported by the Phase III VISIONARY trial data. GlobalData believes that sibeprenlimab’s latest priority review further signifies the drug’s major advantages over existing treatments and will provide enhanced support for its development for targeting a complex condition such as IgAN. If approved, sibeprenlimab could provide patients with the first disease-modifying therapy that addresses both the clinical and practical challenges of living with IgAN.
VISIONARY is an ongoing, randomised, double-blind, placebo-controlled Phase III trial to evaluate the safety and efficacy of sibeprenlimab for IgAN. Interim results showed that sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in the 24-hour urine protein-to-creatinine ratio compared to placebo after nine months of treatment. Additionally, sibeprenlimab demonstrated a favourable safety profile. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks, intended for self-administration at home. This represents a substantial improvement over intravenous therapies that require clinical visits and healthcare facility resources. The self-administration at home provides patients with greater control over their treatment schedule and reduces the disruption to daily activities that often accompany chronic disease management.
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IgAN is a common cause of kidney failure and chronic kidney disease (CKD), which is characterised by a gradual loss of kidney function over time. This leads to the accumulation of excess fluid and waste in the body. In the early stages, CKD is a largely asymptomatic condition.
Otsuka Pharmaceutical acquired Visterra in 2018, enabling the former to expand its research horizons. The FDA Prescription Drug User Fee Act date is set for 28 November 2025.
