Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), in collaboration with Otsuka Pharmaceutical Co., Ltd. (Otsuka), and Visterra, Inc., an Otsuka group company, jointly announce a significant development: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sibeprenlimab, an investigational drug, for the treatment of immunoglobulin A nephropathy (IgAN), commonly known as Berger’s disease. Sibeprenlimab, a humanized monoclonal antibody, targets APRIL (a proliferation-inducing ligand), a B-cell growth factor crucial in IgAN's progression and development.
The Phase 2 ENVISION trial (NCT04287985) for IgAN, whose positive results were shared by Otsuka and Visterra in November 2023 and published in The New England Journal of Medicine, has led to this significant designation.
The Breakthrough therapy designation acknowledges the potential of sibeprenlimab to substantially improve treatment options for serious conditions, signifying a crucial step in addressing IgAN, a prevalent cause of kidney failure. Otsuka and Visterra remain committed to advancing the Phase 3 trial for sibeprenlimab and extend gratitude to study participants, caregivers, and investigators for their invaluable contributions. Immunoglobulin a nephropathy is a primary form of glomerulonephritis globally and a leading cause of kidney failure among young adults.
Despite optimized standard of care therapy, IgAN reduces life expectancy by 10 years, with about 30 percent of patients progressing to kidney failure within 20 to 30 years. Current management strategies involve renin-angiotensin aldosterone system (RAAS) blockers and meticulous blood pressure control, yet the risk of kidney failure remains significant. Sibeprenlimab, the inaugural precision therapy biologic developed by Visterra, holds promise for addressing the substantial unmet medical needs of chronic kidney disease patients.
