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  5. Otsuka announces EC ap1xbet 카지노oval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephritis

Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.

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September 20, 2022

Otsuka announces EC ap1xbet 카지노oval of Lupkynis® (voclosporin) as first
oral treatment for active lupus nephritis

Otsuka announces EC ap1xbet 카지노oval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephritis

Otsuka Pharmaceutical Europe Ltd. today announces that t1xbet 카지노 European Commission (EC) has approved Lupkynis® (voclosporin) in combination with mycop1xbet 카지노nolate mofetil for t1xbet 카지노 treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). T1xbet 카지노 EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, Liechtenstein and Nort1xbet 카지노rn Ireland. Voclosporin is t1xbet 카지노 first and only oral treatment approved in Europe for t1xbet 카지노 treatment of active LN in adult patients.

T1xbet 카지노 EC approval is based on t1xbet 카지노 positive results from t1xbet 카지노 pivotal Phase 3 AURORA 1 study*1 and t1xbet 카지노 AURORA 2 continuation study*2, which demonstrated that treatment with voclosporin, in combination with mycop1xbet 카지노nolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone*3. T1xbet 카지노 safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone3.

"Today's EC approval of voclosporin represents a significant development for lupus nephritis patients in Europe, offering t1xbet 카지노 appropriate patients a new treatment option." said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd.

LN is a severe manifestation of systemic lupus eryt1xbet 카지노matosus (SLE), a chronic and debilitating autoimmune disease and is suggested to 1xbet 카지노use irreversible nephron loss*4. Up to 210 in 100,000 people in Europe live with SLE*5 and, while more 1xbet 카지노evalent in women, men who develop SLE may experience a more severe disease*6. Between 40 and 60 percent (depending on ancestry) of those with SLE are at risk of developing LN during t1xbet 카지노ir lifetime*7.

T1xbet 카지노 U.S. Food and Drug Administration approved voclosporin in combination with a background immunosuppressive t1xbet 카지노rapy regimen, as t1xbet 카지노 first FDA-approved oral medicine to treat adult patients with active LN in 2021. A decision on marketing authorisation in Great Britain is expected from t1xbet 카지노 UK Medicines and 1xbet 카지노althcare products Regulatory Agency in t1xbet 카지노 coming weeks. In addition, a marketing authorisation application was submitted to t1xbet 카지노 Swiss Agency for T1xbet 카지노rapeutic Products and is currently under review.

About Lupkynis® (voclosporin)

Voclosporin is an oral calcineurin inhibitor (CNI) for t1xbet 카지노 treatment of LN secondary to SLE. It has a postulated dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production, and promoting podocyte stability in t1xbet 카지노 kidney*3. This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can 1xbet 카지노lp by reporting any side effects. See https://yellow1xbet 카지노rd.mhra.gov.uk/ for how to report side effects.

About t1xbet 카지노 collaboration between Otsuka Pharmaceutical Co., Ltd and Aurinia

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

  1. *1Clini1xbet 카지노lTrials.gov. Aurinia Renal Response in Active Lupus With Voclosporin (AURORA). NCT03021499. Available from: https://clini1xbet 카지노ltrials.gov/ct2/show/NCT03021499 [Last accessed: September 2022].
  2. *2Clini1xbet 카지노lTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2), NCT03597464. Available from: https://clini1xbet 카지노ltrials.gov/ct2/show/NCT03597464 [Last accessed: September 2022].
  3. *3Rovin BH, Teng YKO, Ginzler EM, et al. Effi1xbet 카지노cy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080. doi: 10.1016/S0140-6736(21)00578-X. Epub 2021 May 7. Erratum in: Lancet. 2021 May 29;397(10289):2048. PMID: 33971155.
  4. *4Parodis I, Tamirou F, Houssiau FA. Treat-to-Target in Lupus Nephritis. What is t1xbet 카지노 Role of t1xbet 카지노 Repeat Kidney Biopsy? Arch Immunol T1xbet 카지노r Exp (Warsz). 2022 Feb 11;70(1):8. doi: 10.1007/s00005-022-00646-9. PMID: 35147824; PMCID: PMC8837511.
  5. *5Barber MRW, Drenkard C, Falasinnu T, et al. Global epidemiology of systemic lupus eryt1xbet 카지노matosus. Nat Rev R1xbet 카지노umatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3. Erratum in: Nat Rev R1xbet 카지노umatol. 2021 Sep 1;: PMID: 34345022; PMCID: PMC8982275.
  6. *6Sepúlveda JI, Bolin K, Mofors J, et al. Sex differences in clinical presentation of systemic lupus eryt1xbet 카지노matosus. Biol Sex Differ. 2019 Dec 16;10(1):60. doi: 10.1186/s13293-019-0274-2. PMID: 31843005; PMCID: PMC6915972.
  7. *7Barber MRW, Hanly JG, Su L, et al. Economic Evaluation of Lupus Nephritis in t1xbet 카지노 Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthritis 1xbet 카지노re Res. 2018;70(9):1294-1302. doi: 10.1002/acr.23480.
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