Otsuka Seeks FDA License for Sibeprenlimab in IgAN

Drug maker Otsuka filed a Biologics License Application with the FDA for the monoclonal antibody sibeprenlimab in the treatment of IgA nephropathy (IgAN). The filing is supported by results from the phase 2 ENVISION trial (NCT04287985) and phase 3 VISIONARY trial (NCT05248646).

VISIONARY was the largest trial in IgAN to date, enrolling 530 participants. The study met its primary endpoint, demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour urine protein to creatine ratio after 9 months of treatment compared with placebo.

Sibeprenlimab selectively inhibits the activity of APRIL (a proliferation-inducing ligand), a cytokine in the tumor necrosis factor family that plays a key role in IgAN pathogenesis and progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every 4 weeks.

“Sibeprenlimab’s unique mechanism of action inhibits the activity of APRIL and addresses an IgA-specific driver of kidney loss in IgA nephropathy. APRIL is a cytokine that plays a key role in the pathogenesis of IgA nephropathy, and we are optimistic about its potential to be an important treatment option for this progressive kidney disease,” said John Kraus, MD, PhD, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, Inc.

Source: Press release