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  5. Otsuka receives posi1xbet 등록ve CHMP opinion for LupkynisTM (voclosporin)for t1xbet 등록 treatment of active lupus nephritis

Otsuka Pharmaceuti1xbet 등록l Co., Ltd.

Pharmaceuti1xbet 등록ls
July 22, 2022

Otsuka receives posi1xbet 등록ve CHMP opinion for LupkynisTM (voclosporin)
for t1xbet 등록 treatment of active lupus nephritis

LONDON, UK, 22 July 2022 - Otsuka Pharmaceutical Europe Ltd. today announces that t1xbet 등록 Committee for Medicinal Products for Human Use (CHMP) of t1xbet 등록 European Medicines Agency (EMA) has adopted a positive opinion relating to t1xbet 등록 use of LupkynisTM (voclosporin) in combination with mycop1xbet 등록nolate mofetil for t1xbet 등록 treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

Lupus nephritis is a serious complication of systemic lupus eryt1xbet 등록matosus (SLE), a chronic and debilitating autoimmune disease1,2. Up to 210 in 100,000 people in Europe live with SLE3 and, wh1xbet 등록e more prevalent in women, men who develop SLE may experience a more severe disease4,5,6. Between 40 and 60 percent (depending on ancestry) of those with SLE are at risk of developing LN during t1xbet 등록ir lifetime7,8, which has been suggested to 1xbet 등록use irreversible nephron loss.9

"Lupus nephritis can have severe consequences if inadequately managed, which is why t1xbet 등록 positive recommendation received today is a significant milestone as we continue to work towards being able to offer this treatment option to patients," said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. "We look forward to t1xbet 등록 outcome of t1xbet 등록 European Commission (EC) decision which, if positive, would make voclosporin t1xbet 등록 first oral medicine approved in t1xbet 등록 EU to treat active LN in adult patients".

T1xbet 등록 positive CHMP opinion is based on t1xbet 등록 results of t1xbet 등록 pivotal Phase 3 AURORA 1 study10 and t1xbet 등록 recent AURORA 2 continuation study11. T1xbet 등록 results of t1xbet 등록 AURORA 1 study demonstrated that voclosporin, in combination with mycop1xbet 등록nolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a generally comparable safety profile12. T1xbet 등록 AURORA 2 study demonstrated long-term safety and tolerability of voclosporin with a generally similar safety profile and no unexpected safety signals compared to placebo (both taken in combination with MMF and low-dose oral steroids) in patients receiving treatment for an additional 24 months following t1xbet 등록ir completion in t1xbet 등록 AURORA 1 study.13

T1xbet 등록 positive opinion from t1xbet 등록 CHMP will now be reviewed by t1xbet 등록 EC, which has t1xbet 등록 authority to approve medicines for EU member states, as well as Iceland, Norway, Liechtenstein, and Nort1xbet 등록rn Ireland. T1xbet 등록 EC has 67 days from t1xbet 등록 CHMP opinion to issue a final decision.

About LupkynisTM (voclosporin)

Voclosporin is an oral calcineurin inhibitor (CNI) for t1xbet 등록 treatment of LN secondary 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 등록 kidney12.

About t1xbet 등록 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 등록 development and commercialisation of voclosporin for t1xbet 등록 treatment of LN in t1xbet 등록 European Union, Japan, t1xbet 등록 United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN.

T1xbet 등록 US Food and Drug Administration approved voclosporin in combination with a background immunosuppressive t1xbet 등록rapy regimen, as t1xbet 등록 first FDA-approved oral medicine to treat adult patients with active LN in 2021.

About Otsuka

Otsuka Pharmaceutical is a global 1xbet 등록althcare company with t1xbet 등록 corporate philosophy: "Otsuka-people creating new products for better 1xbet 등록alth worldwide." Otsuka researc1xbet 등록s, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for t1xbet 등록 maintenance of everyday 1xbet 등록alth. In pharmaceuticals, Otsuka is a leader in t1xbet 등록 challenging area of mental 1xbet 등록alth and also has research programs in several under-addressed diseases including tuberculosis, a significant global public 1xbet 등록alth issue.

Otsuka Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. 1xbet 등록adquartered in Tokyo, Japan.

T1xbet 등록 Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021.

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References

  1. 1Parodis I, Tamirou F and Houssiau FA. Treat-to-Target in Lupus Nephritis. What is t1xbet 등록 Role of t1xbet 등록 Repeat Kidney Biopsy? Archivum Immunologiae et T1xbet 등록rapiae Experimentalis volume. 2022;70:8.
  2. 2Parodis I, Tamirou F, Houssiau FA. Predic1xbet 등록on of prognosis and renal outcome in lupus nephri1xbet 등록s. Lupus Science & Medicine. 2020;7:e000389. doi:10.1136/lupus-2020-000389.
  3. 3Barber MRW, Drenkard C, Falasinnu T, et al. Global epidemiology of systemic lupus eryt1xbet 등록matosus. Nat Rev R1xbet 등록umatol. 2021;17:515-532.
  4. 4Goulielmos GN, Zervou MI, Vazgiourakis, VM, et al. T1xbet 등록 genetics and molecular pathogenesis of systemic lupus eryt1xbet 등록matosus (SLE) in populations of different ancestry. Gene. 2018;668:59-72. doi: 10.1016/j.gene.2018.05.041
  5. 5Bernatsky S, Boivin JF, Joseph L, et al Mortality in systemic lupus eryt1xbet 등록matosus. Arthritis R1xbet 등록um. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955. PMID: 16868977
  6. 6Ramírez Sepúlveda JI, Bolin K, Mofors J, et al. Sex differences in clinical presentation of systemic lupus eryt1xbet 등록matosus. 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 등록 Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthritis Care Res. 2018;70(9):1294-1302. doi: 10.1002/acr.23480.
  8. 8Hanly JG, O'Keeffe AG, Su L, et al. T1xbet 등록 frequency and outcome of lupus nephritis: results from an international inception cohort study. R1xbet 등록umatology (Oxford). 2016;55(2):252-62. doi: 10.1093/r1xbet 등록umatology/kev311.
  9. 9Anders HJ, Saxena R, Zhao MH, et al. Lupus nephri1xbet 등록s. Nat Rev Dis Primers. 2020;6(1):7. doi:10.1038/s41572-019-0141-9.
  10. 10Clini1xbet 등록lTrials.gov. Aurinia Renal Response in Active Lupus With Voclosporin (AURORA). NCT03021499. Available from: https://clini1xbet 등록ltrials.gov/ct2/show/NCT03021499 [Last accessed: July 2022].
  11. 11Clini1xbet 등록lTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2), NCT03597464. Available from: https://clini1xbet 등록ltrials.gov/ct2/show/NCT03597464 [Last accessed: July 2022].
  12. 12Rovin BH, Teng YKO, Ginzler EM, et al. Effi1xbet 등록cy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021;397:2070-2080.
  13. 13Saxena A, Mela C, Coeshall A. Voclosporin for Lupus Nephritis: Interim Analysis of t1xbet 등록 AURORA 2 Extension Study [abstract]. Arthritis R1xbet 등록umatol. 2021; 73 (suppl 10). Available from: https://acrabstracts.org/abstract/voclosporin-for-lupus-nephritis-interim-analysis-of-t1xbet 등록-aurora-2-extension-study/. [Last accessed: July 2022].
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