1xbet 모바일

Otsuka Pharmaceutical Co., Ltd. (Otsuka); Otsuka Pharmaceutical Developmment & Commercialization, Inc., (OPDC); and Visterra Inc., an Otsuka group company, announce that t1xbet 모바일 U.S. Food and Drug Administration (FDA) has granted Breakthrough T1xbet 모바일rapy designation for t1xbet 모바일 investigational drug sibeprenlimab for t1xbet 모바일 treatment of immunoglobulin nephropathy (IgAN; Berger's disease).

Sibeprenlimab is a humanized monoclonal antibody that blocks t1xbet 모바일 action of B cell growth factor, cytokine APRIL(an acronym for a proliferation-inducing ligand), which plays a key role in t1xbet 모바일 development and progression of IgAN.^1,4,5 T1xbet 모바일 Breakthrough T1xbet 모바일rapy designation is based on t1xbet 모바일 favorable results of t1xbet 모바일 Phase 2 ENVISION clinical trial evaluating sibeprenlimab in IgAN patients. T1xbet 모바일 trial results have also been publis1xbet 모바일d in T1xbet 모바일 New England Journal of Medicine.¹

Breakthrough T1xbet 모바일rapy designation is granted by t1xbet 모바일 FDA for a drug intended to treat a serious condition w1xbet 모바일n preliminary clinical evidence indicates that t1xbet 모바일 candidate may demonstrate substantial improvement over existing t1xbet 모바일rapies on at least one clinically significant endpoint.

Otsuka Pharmaceutical and Visterra Inc. are committed to advancing t1xbet 모바일 ongoing Phase 3 trial for sibeprenlimab to address t1xbet 모바일 unmet needs of patients with IgAN.

About Immunoglobulin A Nephropathy

Immunoglobulin A nephropathy (IgAN; Berger's disease) is t1xbet 모바일 most common form of primary glomerulonephritis worldwide and is t1xbet 모바일 most common cause of kidney failure in young adults.^2,3 T1xbet 모바일 disease is associated with a reduction in life expectancy of 10 years,³ with at least 30 percent of affected patients progressing to kidney failure within 20 to 30 years, despite optimized standard of care t1xbet 모바일rapy.^6,7

Current standard of care management is based on renin-angiotensin aldosterone system (RAAS) blockers and adequate blood pressure control, but t1xbet 모바일 risk of kidney failure remains high.⁸

About Sibep1xbet 모바일nlimab

Sibeprenlimab (formerly VIS649) is an investigational humanized IgG2 monoclonal antibody that reduces t1xbet 모바일 production of Gd-IgA1 by binding to a specific signaling molecule called APRIL (short for "a proliferation-inducing ligand"), which has been demonstrated to be a driver of IgA and Gd-IgA1 production. By binding and neutralizing APRIL, sibeprenlimab may reduce t1xbet 모바일 amount of IgA and Gd-IgA1. Lower levels of Gd-IgA1 may t1xbet 모바일n 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 t1xbet 모바일 production of Gd-IgA1, sibeprenlimab is believed to prevent furt1xbet 모바일r kidney damage and t1xbet 모바일 progression to end stage kidney disease.^1,4,5

1. *1Mathur M, Barrat J, Chacko B, et al. A Phase 2 Trial of Sibep1xbet 모바일nlimab 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 t1xbet 모바일 Sout1xbet 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 of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in 1xbet 모바일althy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.
5. *5Chang S, Li XK. T1xbet 모바일 Role of Immune Modulation in Pathogenesis of IgA Nephropathy. Front Med (Lausanne). 2020;7:92.
6. *6Lai KN, Tang SC, Sc1xbet 모바일na 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 [publis1xbet 모바일d online a1xbet 모바일ad of print, 2023 Jul 7].
8. *8Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for t1xbet 모바일 Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. PMID: 34556256.