Sibeprenlimab's Priority Review Highlights Potential to Differentiate in IgAN Space

Otsuka Pharmaceutical recently announced that the FDA has accepted for review the Biologics License Application (BLA) for sibeprenlimab, which acts as 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. If approved, sibeprenlimab could provide patients with the first disease-modifying therapy that addresses both the clinical and practical challenges of living with IgAN, says GlobalData, a leading data and analytics company.

VISIONARY is an ongoing, randomized, double-blind, placebo-controlled Phase 3 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 24-hour urine protein-to-creatinine ratio compared to placebo after nine months of treatment. Additionally, sibeprenlimab demonstrated a favorable safety profile.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments “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 accompanies chronic disease management.”

IgAN is a common cause of chronic kidney disease (CKD) and kidney failure. CKD is a condition characterized 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.

Jaddoo concludes “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 like IgAN.”

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