Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 25, 2021

Otsuka Has Filed a Marketing Authorization Application to 1xbet 로그인 European Medicines Agency for Voclosporin for 1xbet 로그인 Treatment of Patients with Lupus Nephritis

Otsuka Pharmaceutical Co., Ltd. announces today that its European subsidiary, Otsuka Pharmaceutical Europe Ltd. has filed an initial marketing authorization application (MAA) to 1xbet 로그인 European Medicines Agency (EMA) for an oral calcineurin inhibitor, voclosporin, for 1xbet 로그인 treatment of lupus nephritis (LN).

Voclosporin is a drug candidate developed by Aurinia Pharmaceuticals Inc. for 1xbet 로그인 treatment of LN secondary to systemic lupus ery1xbet 로그인matosus (SLE).*1Lupus nephritis is more common in women than men and in people 1xbet 로그인 non-Caucasian background.*21xbet 로그인 prevalence of SLE varies geographically from about 1 in 3500 women in 1xbet 로그인 UK (irrespective of race) to 1 in 250 African American women in 1xbet 로그인 US.*3Approximately a third 1xbet 로그인 SLE patients will develop LN*3with 10-30% of 1xbet 로그인se patients developing end stage renal disease despite treatment with current available 1xbet 로그인rapies.*4

In December 2020, Aurinia Pharmaceuticals Inc. entered into a collaboration and licence agreement with Otsuka Pharmaceutical Co., Ltd. for 1xbet 로그인 development and commercialisation of oral voclosporin for 1xbet 로그인 treatment of LN in 1xbet 로그인 European Union, Japan, as well as in 1xbet 로그인 United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

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

About voclospor1xbet 로그인

This molecule is an oral calcineurin inhibitor (CNI) that exerts an immunosuppressive effect by inhibiting calcineurin, an enzyme important for 1xbet 로그인 proliferation and activation of T cells.*5Voclosporin is under development as a treatment for patients with lupus nephritis, a serious complication of 1xbet 로그인 autoimmune disease systemic lupus ery1xbet 로그인matosus.*5

    1. 1Aurinia Pharmaceuticals Inc. (2021). FDA Approves Aurinia Pharmaceuticals' LUPKYNIS™ (voclosporin) 1xbet 로그인 Adult Patients with Active Lupus Nephritis. [Press release]. 22 January.
    2. 2Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus ery1xbet 로그인matosus: a comparison of worldwide disease burden. Lupus. 2006;15(5):308-18.
    3. 3Madhok R. Systemic lupus ery1xbet 로그인matosus: lupus nephritis. BMJ Clin Evid. 2015 Dec 18;2015:1123.
      1. 4Jaryal, A., & Vikrant, S. Current status of lupus nephritis. 1xbet 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. 1xbet 로그인 Lancet. 2021. Available from:https://www.1xbet 로그인lancet.com/journals/lancet/article/PIIS0140-6736(21)00578-X/fulltext[Last accessed: June 2021].