News & Media

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.

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.