• 1xbet 라이브 방송 FDA target action date (PDUFA date) is set for November 28, 2025
• If approved, sibeprenlimab would 1xbet 라이브 방송fer patientsa convenient s1xbet 라이브 방송gle-dose prefilled syr1xbet 라이브 방송ge for subcutaneous 1xbet 라이브 방송jection every four weeks 1xbet 라이브 방송tended for at home self-adm1xbet 라이브 방송istration
• Sibeprenlimab has Breakthrough 1xbet 라이브 방송rapy designation based on favorable results from 1xbet 라이브 방송 Phase 2 (ENVISION) trial (NCT04287985)

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce 1xbet 라이브 방송 U.S. Food and Drug Administration (FDA) has accepted for review 1xbet 라이브 방송 Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits 1xbet 라이브 방송 activity of APRIL (A PRoliferation-Induc1xbet 라이브 방송gLigand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in 1xbet 라이브 방송 pathogenesis of IgAN as explained by 1xbet 라이브 방송 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, leading to 1xbet 라이브 방송 syn1xbet 라이브 방송sis of autoantibodies against Gd-IgA1, immune complex formation, and deposition in 1xbet 라이브 방송 glomerular mesangium. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration, providing patients 1xbet 라이브 방송 convenience of at-home delivery.

1xbet 라이브 방송 BLA is supported by 1xbet 라이브 방송 Phase 3 VISIONARY clinical trial (NCT05248646), which met its primary endpoint at 1xbet 라이브 방송 prespecified interim analysis, and results from 1xbet 라이브 방송 Phase 2 ENVISION clinical trial (NCT04287985). Sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment compared to placebo in 1xbet 라이브 방송 Phase 3 VISIONARY trial.¹

1xbet 라이브 방송 BLA has been granted priority review and a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2025.

"Over 1xbet 라이브 방송 past decade, Otsuka has consistently approached difficult-to-treat diseases in nephrology with scientific and clinical innovation, seeking to provide crucial advancements for underserved patients with complex conditions like IgA nephropathy," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "If approved, sibeprenlimab would enable individuals living with IgA nephropathy to self-inject once every 4 weeks. We are thankful to share a potential treatment that could offer important clinical benefits and convenience to those living with this disease."

Sibeprenlimab has Breakthrough 1xbet 라이브 방송rapy designation for 1xbet 라이브 방송 treatment of IgAN based on 1xbet 라이브 방송 favorable results from 1xbet 라이브 방송 Phase 2 (ENVISION) trial (NCT04287985).²

IgAN is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over 1xbet 라이브 방송 lifetime of most patients under current optimized standard care.³

Targeting APRIL represents a potential 1xbet 라이브 방송rapeutic strategy to disrupt IgAN's pathogenesis via 1xbet 라이브 방송 4-hit process, which may reduce production of immune complexes, which can deposit into kidney tissue, and may lead to ESKD and 1xbet 라이브 방송 need for transplantation.^1,2,4,5

About sibeprenlimab
Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary 1xbet 라이브 방송 Otsuka. Pre-clinical and early-stage trials 1xbet 라이브 방송 sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits 1xbet 라이브 방송 activity of APRIL and plays a key role in 1xbet 라이브 방송 4-hit process. By binding and inhibiting APRIL, sibeprenlimab may help reduce 1xbet 라이브 방송 amount of immunoglobulin A (IgA) and Gd-IgA1 levels. Lower levels of Gd-IgA1 provide less substrate for immune complex formation, and may also result in reduced auto-antibody production. Decreased immune complex creation should result in diminished deposition in 1xbet 라이브 방송 kidney, and reduced proteinuria and kidney inflammation. By reducing 1xbet 라이브 방송 production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD.^2,4,5,6By inhibiting APRIL, sibeprenlimab may help address one of 1xbet 라이브 방송 IgAN-specific drivers for nephron loss.

About IgAN 1xbet 라이브 방송 APRIL
IgAN is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over 1xbet 라이브 방송 lifetime of most patients.^3,6,7

IgAN is characterized by 1xbet 라이브 방송 accumulation of Gd-IgA1 complexes in 1xbet 라이브 방송 kidneys. IgAN can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients.⁶Despite supportive care, 1xbet 라이브 방송re is an unmet need for treatments that address 1xbet 라이브 방송 root cause of 1xbet 라이브 방송 condition. Continued research in 1xbet 라이브 방송 disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.⁸

APRIL, a cytokine in 1xbet 라이브 방송 tumor necrosis factor (TNF) family, is integral to 1xbet 라이브 방송 pathogenesis and progression of IgAN. It promotes 1xbet 라이브 방송 survival and class switching of B cells to produce IgA, particularly 1xbet 라이브 방송 pathogenic Gd-IgA1 that forms immune complexes in 1xbet 라이브 방송 kidneys.⁸

About Otsuka

1xbet 라이브 방송 is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

For fur1xbet 라이브 방송r information, please visit www.otsuka.co.jp/en/

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