June 25, 2021
Otsuka Pharmaceutical Co., Ltd.
Otsuka Has Filed a Marketing Authorization Application to the European Medicines Agency for Voclosporin for the Treatment of Patients with Lupus Nephritis
Otsuka Pharmaceutical Co., Ltd. announces today that its European subsidiary, Otsuka Pharmaceutical Europe Ltd. has filed an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for an oral calcineurin inhibitor, voclosporin, for the treatment of lupus nephritis (LN).
Voclosporin is a drug candidate developed by Aurinia Pharmaceuticals Inc. for the treatment of LN secondary to systemic lupus erythematosus (SLE).*1 Lupus nephritis is more common in women than men and in people of non-Caucasian background.*2 The prevalence of SLE varies geographically from about 1 in 3500 women in the UK (irrespective of race) to 1 in 250 African American women in the US.*3 Approximately a third of SLE patients will develop LN*3 with 10-30% of these patients developing end stage renal disease despite treatment with current available therapies.*4
In December 2020, Aurinia Pharmaceuticals Inc. entered into a collaboration and licence agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialisation of oral voclosporin for the treatment of LN in the European Union, Japan, as well as in the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
In January 2021, the US FDA approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN.*1
This molecule is an oral calcineurin inhibitor (CNI) that exerts an immunosuppressive effect by inhibiting calcineurin, an enzyme important for the proliferation and activation of T cells.*5 Voclosporin is under development as a treatment for patients with lupus nephritis, a serious complication of the autoimmune disease systemic lupus erythematosus.*5
- 1Aurinia Pharmaceuticals Inc. (2021). FDA Approves Aurinia Pharmaceuticals' LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis. [Press release]. 22 January.
- 2Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus. 2006;15(5):308-18.
- 3Madhok R. Systemic lupus erythematosus: lupus nephritis. BMJ Clin Evid. 2015 Dec 18;2015:1123.
- 4Jaryal, A., & Vikrant, S. Current status of lupus nephritis. The Indian journal of medical research. 2017; 145(2), 167-178.
- 5Rovin, BH et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet. 2021. Available from: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00578-X/fulltext [Last accessed: June 2021].
Information in this news release was current as of the original release date.