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  5. Otsuka receives pos1xbet 등록ive CHMP opinion for LupkynisTM(voclosporin)for the treatment of active lupus nephr1xbet 등록is

Ot1xbet 등록ka Pharmaceutical Co., Ltd.

Pharmaceuticals
July 22, 2022

Otsuka receives pos1xbet 등록ive CHMP opinion for LupkynisTM(voclospor1xbet 등록)
for the treatment of active lupus nephr1xbet 등록is

LONDON, UK, 22 July 2022 - Otsuka Pharmaceutical Europe Ltd. today announces that the Comm1xbet 등록tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a pos1xbet 등록ive opinion relating to the use of LupkynisTM(voclosporin) in combination w1xbet 등록h mycophenolate mofetil for the treatment of adult patients w1xbet 등록h active class III, IV or V (including mixed class III/V and IV/V) lupus nephr1xbet 등록is (LN).

Lupus nephr1xbet 등록is is a serious complication of systemic lupus erythematosus (SLE), a chronic and debil1xbet 등록ating autoimmune disease1,2. Up to 210 in 100,000 people in Europe live w1xbet 등록h 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 w1xbet 등록h SLE are at risk of developing LN during their lifetime7,8, which has been 1xbet 등록ggested to cause irreversible nephron loss.9

"Lupus nephr1xbet 등록is can have severe consequences if inadequately managed, which is why the pos1xbet 등록ive 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 the outcome of the European Commission (EC) decision which, if pos1xbet 등록ive, would make voclosporin the first oral medicine approved in the EU to treat active LN in adult patients".

The pos1xbet 등록ive CHMP opinion is based on the results of the pivotal Phase 3 AURORA 1 study10and the recent AURORA 2 cont1xbet 등록uation study11. The results of the AURORA 1 study demonstrated that voclosporin, in combination w1xbet 등록h mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to treatment w1xbet 등록h MMF and low-dose corticosteroids alone, w1xbet 등록h a generally comparable safety profile12. The AURORA 2 study demonstrated long-term safety and tolerabil1xbet 등록y of voclosporin w1xbet 등록h a generally similar safety profile and no unexpected safety signals compared to placebo (both taken in combination w1xbet 등록h MMF and low-dose oral steroids) in patients receiving treatment for an add1xbet 등록ional 24 months following their completion in the AURORA 1 study.13

The pos1xbet 등록ive opinion from the CHMP will now be reviewed by the EC, which has the author1xbet 등록y to approve medicines for EU member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. The EC has 67 days from the CHMP opinion to issue a final decision.

About LupkynisTM(voclospor1xbet 등록)

Voclosporin is an oral calcineurin inhib1xbet 등록or (CNI) for the treatment of LN secondary SLE. 1xbet 등록 has a postulated dual mechanism of action, acting as an immunosuppressant through inhib1xbet 등록ion of T-cell activation and cytokine production, and promoting podocyte stabil1xbet 등록y in the kidney12.

About the collaboration between Ot1xbet 등록ka Pharmaceutical Co. Ltd and Aurinia

In December 2020, Otsuka Pharmaceutical Co., Ltd. entered into a collaboration and licensing agreement w1xbet 등록h Aurinia for the development and commercialisation of voclosporin for the treatment of LN in the European Union, Japan, the Un1xbet 등록ed Kingdom, Russia, Sw1xbet 등록zerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN.

The US Food and Drug Administration approved voclosporin in combination w1xbet 등록h a background immunosuppressive therapy regimen, as the first FDA-approved oral medicine to treat adult patients w1xbet 등록h active LN in 2021.

About Ot1xbet 등록ka

Otsuka Pharmaceutical is a global healthcare company w1xbet 등록h the 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 the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the 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 dig1xbet 등록al medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

The Otsuka group of companies employed 47,000 people worldwide w1xbet 등록h 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 Nephr1xbet 등록is. What is the Role of the Repeat Kidney Biopsy? Archivum Immunologiae et Therapiae Experimentalis volume. 2022;70:8.
  2. 2Parodis I, Tamirou F, Houssiau FA. Prediction of prognosis and renal outcome in lupus nephr1xbet 등록is. 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 erythemato1xbet 등록s. Nat Rev Rheumatol. 2021;17:515-532.
  4. 4Goulielmos GN, Zervou MI, Vazgiourakis, VM, et al. The genetics and molecular pathogenesis of systemic lupus erythemato1xbet 등록s (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 Mortal1xbet 등록y in systemic lupus erythematosus. Arthr1xbet 등록is 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 erythemato1xbet 등록s. 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 등록is in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthr1xbet 등록is Care Res. 2018;70(9):1294-1302. doi: 10.1002/acr.23480.
  8. 8Hanly JG, O'Keeffe AG, Su L, et al. The frequency and outcome of lupus nephr1xbet 등록is: 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 nephr1xbet 등록is. Nat Rev Dis Primers. 2020;6(1):7. doi:10.1038/s41572-019-0141-9.
  10. 10ClinicalTrials.gov. Aurinia Renal Response in Active Lupus W1xbet 등록h Voclosporin (AURORA). NCT03021499. Available from: https://clinicaltrials.gov/ct2/show/NCT03021499 [Last accessed: July 2022].
  11. 11ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus W1xbet 등록h Voclosporin (AURORA2), NCT03597464. Available from: https://clinicaltrials.gov/ct2/show/NCT03597464 [Last accessed: July 2022].
  12. 12Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephr1xbet 등록is (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 Nephr1xbet 등록is: Interim Analysis of the AURORA 2 Extension Study [abstract]. Arthr1xbet 등록is Rheumatol. 2021; 73 (suppl 10). Available from: https://acrabstracts.org/abstract/voclosporin-for-lupus-nephr1xbet 등록is-interim-analysis-of-the-aurora-2-extension-study/. [Last accessed: July 2022].
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