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01-Dec-2022

Otsuka announces MHRA authorisation of Lupkynis® (voclosporin) as first oral calcineurin-inhibitor ▼ (CNI) for active lupus nephritis

LONDON, UK, 30 November 2022 – Otsuka Pharmaceuticals UK Ltd. announces that the MHRA (Medicines and Healthcare Products Regulatory Agency) has authorised Lupkynis® (voclosporin) for use in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). The MHRA decision applies to England, Scotland, and Wales (Great Britain). Voclosporin is the first and only oral CNI licensed in Great Britain (GB) specifically for the treatment of active LN in adult patients. 

“The MHRA’s authorisation of Lupkynis represents a significant development for lupus nephritis patients in Great Britain, offering voclosporin as a new combination treatment option for eligible patients.” said Ryan Gynne, Managing Director of Otsuka Pharmaceuticals UK Ltd. 

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease, that can cause irreversible kidney damage4. UK data from 2012 showed that around 60,000 people were living with SLE and around 3,000* people were diagnosed with SLE each year5. Around 40% to 60% of people with SLE develop lupus nephritis6,7.

About voclosporin

Voclosporin is a calcineurin-inhibitor immunosuppressant that inhibits calcineurin in a dose-dependent manner up to a maximum dose of 1.0mg/kg. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens8.

▼ This medicine is subject to additional monitoring in relation to adverse reactions. This will allow quick identification of new safety information. See https://yellowcard.mhra.gov.uk/ for how to report side effects.

About AURORA Clinical Trials

The AURORA-1 study (completed in October 2019) was a phase 3, prospective, double-blind, randomised trial comparing voclosporin + MMF + corticosteroids (n=179) vs. placebo + MMF + corticosteroids (n=178) in patients with active LN class III, IV, or V (alone or in combination with class III or IV). The primary endpoint was to assess the efficacy of voclosporin compared with placebo in achieving renal response at 52 weeks of therapy; 73 (40.8%) and 40 (22.5%) patients in the voclosporin and placebo arms respectively, achieved this (p<0.001)8. Safety and adverse events were assessed through laboratory assessments, vital signs, and physical examinations1.The AURORA-2 study (completed in October 2021) was an extension to assess the long-term safety and efficacy of voclosporin (n=116) compared with placebo (n=100) for up to an additional 24 months in patients that completed treatment in the AURORA-1 study8

About the 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 the development and commercialisation of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

About voclosporin in other territories

The U.S. Food and Drug Administration authorised voclosporin for use in combination with a background immunosuppressive therapy regimen, as the first FDA-authorised oral medicine to treat adult patients with active LN in 2021. The European Commission (EC) has also authorised voclosporin for use in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) LN. The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, Liechtenstein and Northern Ireland. 

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with 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 digital 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 with consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021.

*Data from 1999 to 2012

References

  1. Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy 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          
  2. ClinicalTrials.gov. Aurinia Renal Response in Active Lupus With Voclosporin (AURORA). NCT03021499. Available from: https://clinicaltrials.gov/ct2/show/NCT03021499 [Last accessed: November 2022].
  3. ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2), NCT03597464. Available from: https://clinicaltrials.gov/ct2/show/NCT03597464 [Last accessed: November 2022].
  4. Parodis I, Tamirou F, Houssiau FA. Treat-to-Target in Lupus Nephritis. What is the Role of the Repeat Kidney Biopsy? Arch Immunol Ther Exp (Warsz). 2022 Feb 11;70(1):8.
  5. Rees F, Doherty M, Grainge M et al. The incidence and prevalence of systemic lupus erythematosus in the UK, 1999-2012. Ann Rheum Dis. 2016 Jan;75(1):136-41.
  6. Fanouriakis A, Kostopoulou M, Cheema K et al. 2019 Update of the Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis. Ann Rheum Dis. 2020 Jun;79(6):713-723.
  7. Saxena R, Mahajan T, Mohan C. Lupus nephritis: current update. Arthritis Res Ther. 2011;13(5):240.
  8. Lupkynis EU Summary of product characteristics (SmPC) [last accessed: November 2022].