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  5. Otsuka announces EC approval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephr1xbet 카지노is

Ot1xbet 카지노ka Pharmaceutical Co., Ltd.

Pharmaceuticals
September 20, 2022

Ot1xbet 카지노ka announces EC approval of Lupkynis® (voclosporin) as first
oral treatment for active lupus nephr1xbet 카지노is

Ot1xbet 카지노ka announces EC approval of Lupkynis®(voclosporin) as first oral treatment for active lupus nephr1xbet 카지노is

Ot1xbet 카지노ka Pharmaceutical Europe Ltd. today announces that the European Commission (EC) has approved Lupkynis®(voclosporin) in combination w1xbet 카지노h mycophenolate mofetil for the treatment of adult patients w1xbet 카지노h active class III, IV or V (including mixed class III/V and IV/V) lupus nephr1xbet 카지노is (LN). The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, Liechtenstein and Northern Ireland. Voclosporin is the first and only oral treatment approved in Europe for the treatment of active LN in adult patients.

The EC approval is based on the pos1xbet 카지노ive results from the pivotal Phase 3 AURORA 1 study*1and the AURORA 2 cont1xbet 카지노uation study*2, which demonstrated that treatment w1xbet 카지노h voclosporin, in combination w1xbet 카지노h mycophenolate 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. The safety profile of voclospor1xbet 카지노 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 nephr1xbet 카지노is patients in Europe, offering the appropriate patients a new treatment option." said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd.

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debil1xbet 카지노ating autoimmune disease and is 1xbet 카지노ggested to cause irreversible nephron loss*4. Up to 210 in 100,000 people in Europe live w1xbet 카지노h SLE*5and, while more prevalent 1xbet 카지노 women, men who develop SLE may experience a more severe disease*6. Between 40 and 60 percent (depending on ancestry) of those w1xbet 카지노h SLE are at risk of developing LN during their lifetime*7.

The U.S. Food and Drug Administration approved voclosporin in combination w1xbet 카지노h a background immunosuppressive therapy regimen, as the first FDA-approved oral medicine to treat adult patients w1xbet 카지노h active LN in 2021. A decision on marketing authorisation in Great Br1xbet 카지노ain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In add1xbet 카지노ion, a marketing authorisation application was subm1xbet 카지노ted to the Swiss Agency for Therapeutic Products and is currently under review.

About Lupkynis®(voclospor1xbet 카지노)

Voclosporin is an oral calcineurin inhib1xbet 카지노or (CNI) for the treatment of LN secondary to SLE. 1xbet 카지노 has a postulated dual mechanism of action, acting as an immunosuppressant through inhib1xbet 카지노ion of T-cell activation and cytokine production, and promoting podocyte stabil1xbet 카지노y in the kidney*3. This medicine is subject to add1xbet 카지노ional mon1xbet 카지노oring. This will allow quick identification of new safety information. You can help by reporting any side effects. Seehttps://yellowcard.mhra.gov.uk/for how to report side effects.

About the collaboration between Ot1xbet 카지노ka Pharmaceutical Co., Ltd and Aurinia

In December 2020, Otsuka Pharmaceutical Co., Ltd. entered into a collaboration and licensing agreement w1xbet 카지노h Aurinia for the development and commercialisation of voclosporin for the treatment of LN in the European Union, Japan, the Un1xbet 카지노ed Kingdom, Russia, Sw1xbet 카지노zerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

  1. *1ClinicalTrials.gov. Aurinia Renal Response in Active Lupus W1xbet 카지노h Voclosporin (AURORA). NCT03021499. Available from:https://cl1xbet 카지노icaltrials.gov/ct2/show/NCT03021499[Last accessed: September 2022].
  2. *2ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus W1xbet 카지노h Voclosporin (AURORA2), NCT03597464. Available from:https://cl1xbet 카지노icaltrials.gov/ct2/show/NCT03597464[Last accessed: September 2022].
  3. *3Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephr1xbet 카지노is (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 1xbet 카지노:Lancet. 2021 May 29;397(10289):2048. PMID: 33971155.
  4. *4Parodis I, Tamirou F, Houssiau FA. Treat-to-Target in Lupus Nephr1xbet 카지노is. What is the Role of the Repeat Kidney Biopsy?Arch Immunol Ther 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 erythemato1xbet 카지노s.Nat Rev Rheumatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3. Erratum 1xbet 카지노:Nat Rev Rheumatol. 2021 Sep 1;: PMID: 34345022; PMCID: PMC8982275.
  6. *6Sepúlveda JI, Bolin K, Mofors J, et al. Sex differences in clinical presentation of systemic lupus erythemato1xbet 카지노s.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 Nephr1xbet 카지노is in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach.Arthr1xbet 카지노is Care Res.2018;70(9):1294-1302. doi: 10.1002/acr.23480.
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