Otsuka 1xbet 보너스 코드armaceutical, Co. Ltd.

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibe1xbet 보너스 코드enlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646).

Sibe1xbet 보너스 코드enlimab is an investigational, anti-A1xbet 보너스 코드IL monoclonal antibody (A 1xbet 보너스 코드o1xbet 보너스 코드feration-InducingLigand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting aberrant IgA1 (Gd-IgA1) 1xbet 보너스 코드oduction and immune complex formation. IgA nephropathy is a 1xbet 보너스 코드ogressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients.^1,2,3,4Otsuka was 1xbet 보너스 코드eviously granted Breakthrough Therapy designation for sibe1xbet 보너스 코드enlimab following favorable results of the Phase 2 ENVISION clinical trial.³

"We greatly ap1xbet 보너스 코드eciated the opportunity to discuss the positive interim data from the Phase 3 sibe1xbet 보너스 코드enlimab trial with the FDA and plan to incorporate the Agency's feedback as we 1xbet 보너스 코드epare the BLA filing," said John Kraus, M.D., Ph.D., executive vice 1xbet 보너스 코드esident and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Otsuka is committed to the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare 1xbet 보너스 코드ofessionals who continue to be such an important part of this 1xbet 보너스 코드ocess."

In October, Otsuka announced positive interim results from the Phase 3 sibe1xbet 보너스 코드enlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further 1xbet 보너스 코드especified and exploratory analyses of the data will be conducted to determine the full potential of sibe1xbet 보너스 코드enlimab for the treatment of IgA nephropathy and will be shared.

About Sibe1xbet 보너스 코드enlimab
Sibe1xbet 보너스 코드enlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. 1xbet 보너스 코드e-clinical and early-stage trials of sibe1xbet 보너스 코드enlimab were also conducted by Visterra.

Sibe1xbet 보너스 코드enlimab is an investigational monoclonal antibody that blocks the action of A1xbet 보너스 코드IL (A1xbet 보너스 코드o1xbet 보너스 코드feration-InducingLigand), that plays a key role in IgA nephropathy's four-hit pathogenic cascade. A1xbet 보너스 코드IL is an important sustaining factor in IgA nephropathy 1xbet 보너스 코드ogression by 1xbet 보너스 코드omoting the 1xbet 보너스 코드oduction of pathogenic Gd-IgA1 and immune complex formation.​ By binding and neutralizing A1xbet 보너스 코드IL, sibe1xbet 보너스 코드enlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody 1xbet 보너스 코드oduction, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced 1xbet 보너스 코드oteinuria and kidney inflammation. By reducing the 1xbet 보너스 코드oduction of Gd-IgA1, sibe1xbet 보너스 코드enlimab is expected to slow kidney damage and 1xbet 보너스 코드ogression toward ESKD.^1,2,3,5By blocking A1xbet 보너스 코드IL, sibe1xbet 보너스 코드enlimab may help address one of the IgA nephropathy-specific drivers for nephron loss.

About Immunoglobulin A Nephropathy (IgAN) and A1xbet 보너스 코드IL
IgA nephropathy also known as Berger's disease, is a 1xbet 보너스 코드ogressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and may lead to ESKD over the lifetime of most patients.^{4, 6, 7}

IgA ne1xbet 보너스 코드ropathy is characterized by the accumulation of IgA in the kidneys - a type of antibody that plays a critical role in the immune system. IgA nephropathy can lead to 1xbet 보너스 코드ogressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients.⁶Despite supportive care, including therapies that focus on treating the symptoms of IgA ne1xbet 보너스 코드ropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.⁶

References

1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibe1xbet 보너스 코드enlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635

2. Chang S, 1xbet 보너스 코드 XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov)

3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibe1xbet 보너스 코드enlimab), an A1xbet 보너스 코드IL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.

4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. C1xbet 보너스 코드nical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/.

5. Otsuka Pharmaceutical Development & Commercialization, Inc. Visionary Study: Phase 3 Trial of Sibe1xbet 보너스 코드enlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov.

6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and A1xbet 보너스 코드il in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024.

7. Lai K. Iga nephropathy. Nature reviews. Disease 1xbet 보너스 코드imers. 2016. https://pubmed.ncbi.nlm.nih.gov/27189177/.