Otsuka announces EC approval of Lupkynis®▼ (voclosporin) as first oral treatment for active lupus nephritis

LONDON, UK, 20 September 2022 – Otsuka Pharmaceutical Europe Ltd. today announces that the European Commission (EC) has approved Lupkynis^® (voclosporin) 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 EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, Liechtenstein and Northern Ireland.  Voclosporin is the first and only oral treatment approved in Europe for the treatment of active LN in adult patients. 

“Today’s EC approval of voclosporin represents a significant development for lupus nephritis patients in Europe, offering the appropriate patients a new treatment option.” said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd.

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease and is suggested to cause irreversible nephron loss⁴. Up to 210 in 100,000 people in Europe live with SLE⁵ and, while more prevalent in women, men who develop SLE may experience a more severe disease⁶. Between 40 and 60 percent (depending on ancestry) of those with SLE are at risk of developing LN during their lifetime⁷.

About Lupkynis^® (voclosporin)

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.