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Otsuka Pharmaceutical Co., Ltd. (Otsuka); Otsuka Pharmaceutical Developmment & Commercialization, Inc., (OPDC); and Visterra Inc., an Otsuka group company, announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment 1xbet 모바일 immunoglobulin nephropathy (IgAN; Berger's disease).

Sibeprenlimab is a humanized monoclonal antibody that blocks the action 1xbet 모바일 B cell growth factor, cytokine APRIL(an acronym fora proliferation-induc1xbet 모바일gligand), which plays a key role in the development and progression 1xbet 모바일 IgAN.^1,4,5The Breakthrough Therapy designation is based on the favorable results 1xbet 모바일 the Phase 2 ENVISION clinical trial evaluating sibeprenlimab in IgAN patients. The trial results have also been published inThe New England Journal 1xbet 모바일 Medicine.¹

Breakthrough 1xbet 모바일rapy designation is granted by 1xbet 모바일 FDA for a drug intended to treat a serious condition when preliminary clinical evidence indicates that 1xbet 모바일 candidate may demonstrate substantial improvement over existing 1xbet 모바일rapies on at least one clinically significant endpoint.

Otsuka Pharmaceutical and Visterra Inc. are committed to advancing the ongoing Phase 3 trial for sibeprenlimab to address the unmet needs 1xbet 모바일 patients with IgAN.

About Immunoglobul1xbet 모바일 A Nephropathy

Immunoglobulin A nephropathy (IgAN; Berger's disease) is the most common form 1xbet 모바일 primary glomerulonephritis worldwide and is the most common cause 1xbet 모바일 kidney failure in young adults.^2,3The disease is associated with a reduction in life expectancy 1xbet 모바일 10 years,³with at least 30 percent 1xbet 모바일 affected patients progressing to kidney failure within 20 to 30 years, despite optimized standard 1xbet 모바일 care therapy.^6,7

Current standard 1xbet 모바일 care management is based on renin-angiotensin aldosterone system (RAAS) blockers and adequate blood pressure control, but the risk 1xbet 모바일 kidney failure remains high.⁸

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) is an investigational humanized IgG2 monoclonal antibody that reduces the production 1xbet 모바일 Gd-IgA1 by binding to a specific signaling molecule called APRIL (short for "a proliferation-induc1xbet 모바일gligand"), which has been demonstrated to be a driver 1xbet 모바일 IgA and Gd-IgA1 production. By binding and neutralizing APRIL, sibeprenlimab may reduce the amount 1xbet 모바일 IgA and Gd-IgA1. Lower levels 1xbet 모바일 Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in kidney, and reduced kidney inflammation. By reducing the production 1xbet 모바일 Gd-IgA1, sibeprenlimab is believed to prevent further kidney damage and the progression to end stage kidney disease.^1,4,5

1. *1Mathur M, Barrat J, Chacko B, et al. A Phase 2 Trial 1xbet 모바일 Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
2. *2Floege J, Amann K. Primary glomerulonephritides. Lancet. 2016;387(10032):2036-2048.
3. *3Hastings MC, Bursac Z, Julian BA, et al. Life Expectancy for Patients From 1xbet 모바일 Sou1xbet 모바일astern United States With IgA Nephropathy. Kidney Int Rep. 2017;3(1):99-104.
4. *4Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 1xbet 모바일 VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.
5. *5Chang S, Li XK. The Role 1xbet 모바일 Immune Modulation in Pathogenesis 1xbet 모바일 IgA Nephropathy. Front Med (Lausanne). 2020;7:92.
6. *6Lai KN, Tang SC, Schena FP, et al. IgA nephropathy. Nat Rev Dis Primers. 2016;2:16001.
7. *7Gleeson PJ, O'Shaughnessy MM, Barratt J. IgA nephropathy in adults - Treatment Standard [published online ahead 1xbet 모바일 print, 2023 Jul 7].
8. *8Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management 1xbet 모바일 Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. PMID: 34556256.