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  5. Otsuka receives positive CHMP op1xbet 등록ion for LupkynisTM(voclosporin)for 1xbet 등록 treatment of active lupus nephritis

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
July 22, 2022

Otsuka receives positive CHMP op1xbet 등록ion for LupkynisTM(voclospor1xbet 등록)
for 1xbet 등록 treatment of active lupus nephritis

LONDON, UK, 22 July 2022 - Otsuka Pharmaceutical Europe Ltd. today announces that 1xbet 등록 Committee for Medicinal Products for Human Use (CHMP) of 1xbet 등록 European Medicines Agency (EMA) has adopted a positive opinion relating to 1xbet 등록 use of LupkynisTM(voclosporin) in combination with mycophenolate mofetil for 1xbet 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 ery1xbet 등록matosus (SLE), a chronic and debilitating autoimmune disease1,2. Up to 210 1xbet 등록 100,000 people 1xbet 등록 Europe live with SLE3and, while more prevalent 1xbet 등록 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 1xbet 등록ir lifetime7,8, which has been suggested to cause irreversible nephron loss.9

"Lupus nephritis can have severe consequences if inadequately managed, which is why 1xbet 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 1xbet 등록 outcome of 1xbet 등록 European Commission (EC) decision which, if positive, would make voclosporin 1xbet 등록 first oral medicine approved in 1xbet 등록 EU to treat active LN in adult patients".

1xbet 등록 positive CHMP opinion is based on 1xbet 등록 results of 1xbet 등록 pivotal Phase 3 AURORA 1 study10and 1xbet 등록 recent AURORA 2 continuation study11. 1xbet 등록 results of 1xbet 등록 AURORA 1 study demonstrated that voclosporin, in combination with mycophenolate 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. 1xbet 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 1xbet 등록ir completion in 1xbet 등록 AURORA 1 study.13

1xbet 등록 positive opinion from 1xbet 등록 CHMP will now be reviewed by 1xbet 등록 EC, which has 1xbet 등록 authority to approve medicines for EU member states, as well as Iceland, Norway, Liechtenstein, and Nor1xbet 등록rn Ireland. 1xbet 등록 EC has 67 days from 1xbet 등록 CHMP opinion to issue a final decision.

About LupkynisTM(voclospor1xbet 등록)

Voclosporin is an oral calcineurin inhibitor (CNI) for 1xbet 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 1xbet 등록 kidney12.

About 1xbet 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 1xbet 등록 development and commercialisation of voclosporin for 1xbet 등록 treatment of LN in 1xbet 등록 European Union, Japan, 1xbet 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.

1xbet 등록 US Food and Drug Administration approved voclosporin in combination with a background immunosuppressive 1xbet 등록rapy regimen, as 1xbet 등록 first FDA-approved oral medicine to treat adult patients with active LN in 2021.

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with 1xbet 등록 corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for 1xbet 등록 maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in 1xbet 등록 challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health 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 1xbet 등록 Otsuka Pharmaceutical Company, Ltd., a subsidiary 1xbet 등록 Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

1xbet 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 1xbet 등록 Role of 1xbet 등록 Repeat Kidney Biopsy? Archivum Immunologiae et 1xbet 등록rapiae Experimentalis volume. 2022;70:8.
  2. 2Parodis I, Tamirou F, Houssiau FA. Prediction 1xbet 등록 prognosis and renal outcome in lupus nephritis. 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 ery1xbet 등록matosus. Nat Rev Rheumatol. 2021;17:515-532.
  4. 4Goulielmos GN, Zervou MI, Vazgiourakis, VM, et al. 1xbet 등록 genetics and molecular pathogenesis of systemic lupus ery1xbet 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 ery1xbet 등록matosus. Arthritis Rheum. 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 ery1xbet 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 1xbet 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. 1xbet 등록 frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford). 2016;55(2):252-62. doi: 10.1093/rheumatology/kev311.
  9. 9Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi:10.1038/s41572-019-0141-9.
  10. 10Cl1xbet 등록icalTrials.gov. Aur1xbet 등록ia Renal Response 1xbet 등록 Active Lupus With Voclospor1xbet 등록 (AURORA). NCT03021499. Available from: https://cl1xbet 등록icaltrials.gov/ct2/show/NCT03021499 [Last accessed: July 2022].
  11. 11Cl1xbet 등록icalTrials.gov. Aur1xbet 등록ia Renal Assessments 2: Aur1xbet 등록ia Renal Response 1xbet 등록 Lupus With Voclospor1xbet 등록 (AURORA2), NCT03597464. Available from: https://cl1xbet 등록icaltrials.gov/ct2/show/NCT03597464 [Last accessed: July 2022].
  12. 12Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety 1xbet 등록 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 1xbet 등록 AURORA 2 Extension Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). Available from: https://acrabstracts.org/abstract/voclosporin-for-lupus-nephritis-interim-analysis-of-1xbet 등록-aurora-2-extension-study/. [Last accessed: July 2022].
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