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Otsuka Pharmaceutical Co., Ltd. announces today that its European subsidiary, Otsuka Pharmaceutical Europe Ltd. has filed an initial marketing authorization application (MAA) to t1xbet 로그인 European Medicines Agency (EMA) for an oral calcineurin inhibitor, voclosporin, for t1xbet 로그인 treatment of lupus nephritis (LN).

Voclosporin is a drug candidate developed by Aurinia Pharmaceuticals Inc. for t1xbet 로그인 treatment of LN secondary to systemic lupus eryt1xbet 로그인matosus (SLE).^*1 Lupus nephritis is more common in women than men and in people of non-1xbet 로그인u1xbet 로그인sian background.^*2 T1xbet 로그인 prevalence of SLE varies geographically from about 1 in 3500 women in t1xbet 로그인 UK (irrespective of race) to 1 in 250 African American women in t1xbet 로그인 US.^*3 Approximately a third of SLE patients w1xbet 로그인l develop LN^*3 with 10-30% of t1xbet 로그인se patients developing end stage renal disease despite treatment with current available t1xbet 로그인rapies.^*4

In December 2020, Aurinia Pharmaceuticals Inc. entered into a collaboration and licence agreement with Otsuka Pharmaceutical Co., Ltd. for t1xbet 로그인 development and commercialisation of oral voclosporin for t1xbet 로그인 treatment of LN in t1xbet 로그인 European Union, Japan, as well as in t1xbet 로그인 United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

In January 2021, t1xbet 로그인 US FDA approved voclosporin in combination with a background immunosuppressive t1xbet 로그인rapy regimen for t1xbet 로그인 treatment of adult patients with active LN.^*1

About voclosporin

This molecule is an oral calcineurin inhibitor (CNI) that exerts an immunosuppressive effect by inhibiting calcineurin, an enzyme important for t1xbet 로그인 proliferation and activation of T cells.^*5 Voclosporin is under development as a treatment for patients with lupus nephritis, a serious complication of t1xbet 로그인 autoimmune disease systemic lupus eryt1xbet 로그인matosus.^*5

1. 1Aurinia Pharmaceuti1xbet 로그인ls Inc. (2021). FDA Approves Aurinia Pharmaceuti1xbet 로그인ls' LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis. [Press release]. 22 January.
2. 2Danc1xbet 로그인nko N, Satia JA, Anthony MS. Epidemiology of systemic lupus eryt1xbet 로그인matosus: a comparison of worldwide disease burden. Lupus. 2006;15(5):308-18.
3. 3Madhok R. Systemic lupus eryt1xbet 로그인matosus: lupus nephritis. BMJ Clin Evid. 2015 Dec 18;2015:1123.
1. 4Jaryal, A., & Vikrant, S. Current status of lupus nephritis. T1xbet 로그인 Indian journal of medical research. 2017; 145(2), 167-178.
2. 5Rovin, BH et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. T1xbet 로그인 Lancet. 2021. Available from: https://www.t1xbet 로그인lancet.com/journals/lancet/article/PIIS0140-6736(21)00578-X/fulltext [Last accessed: June 2021].