Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo1. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data1.
Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the pathogenesis of IgAN as explained by the 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, leading to the synthesis of autoantibodies against Gd-IgA1, immune complex formation, and deposition in the glomerular mesangium. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration, providing patients the convenience of at-home delivery.
PBS and WETA Caregiving Documentary by Executive Producer Bradley Cooper Now Available to Stream
Otsuka America Pharmaceutical, Inc., the lead, founding sponsor of a new PBS and WETA documentary created with executive producer and award-winning actor Bradley Cooper, announces that Caregiving is now available to stream on PBS and PBS Documentaries Prime Video Channel. The two-hour documentary portrays paid and unpaid caregivers navigating the challenges and joys of this deeply meaningful work, intertwining intimate personal stories with the untold history of caregiving in the U.S. Otsuka supports this documentary as part of its corporate commitment to raise awareness about the growing urgency to support caregivers, who are frequently the backbone of care in communities across the nation.
New Report Shows Nearly Half of U.S. States Are on the Threshold of a Caregiving Emergency
In the 32 states with predominantly rural populations, unpaid family caregivers contribute over $375 billion in labor, yet a shortage of healthcare workers makes it challenging for families to access necessary support.Dementia care is driving a significant portion of the national family caregiving valuation, contributing to over $340 billion of labor, especially those in states with aging and high-risk populations. This new analysis found that even a 10% increase in dementia care hours would add another $62 billion in unpaid labor nationwide.