Purpose-built for physicians
The FDA granted accelerated approval for sibeprenlimab-szsi to reduce proteinuria for adults with primary immunoglobulin A nephropathy at risk for disease progression, according to an industry press release.
Sibeprenlimab-szsi (Voyxact, Otsuka Pharmaceutical) is the first A-proliferation-inducing-ligand (APRIL) blocker to be approved for treating immunoglobulin A nephropathy (IgAN), according to John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka. It is a self-administered, subcutaneous injection dosed every 4 weeks, he said.
“APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression,” Kraus told Healio. “It promotes the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), which is the first step in the disease onset. By blocking APRIL, Voyxact leads to reduced levels of Gd-IgA1.”
The pivotal trial for FDA approval was the multicenter, double-blind, placebo-controlled phase 3 VISIONARY trial. An interim analysis demonstrated a significant placebo-adjusted treatment effect in proteinuria reduction after 9 months of treatment with sibeprenlimab-szsi vs. placebo (–50% vs. 2%) for 320 patients with an IgAN diagnosis and eGFR greater than 30 mL/min/1.73 m² on a stable dose of supportive therapy.
