The European Commission (EC) has approved Otsuka Pharmaceutical Europe Ltd’s 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.
The EC approval is based on the positive results from the pivotal Phase 3 AURORA 1 study and the AURORA 2 continuation study, which demonstrated that treatment with voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
“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 loss. Up to 210 in 100,000 people in Europe live with SLE and, while more prevalent in women, men who develop SLE may experience a more severe disease. Between 40 and 60 percent (depending on ancestry) of those with SLE are at risk of developing LN during their lifetime.
The U.S. Food and Drug Administration approved voclosporin in combination with a background immunosuppressive therapy regimen, as the first FDA-approved oral medicine to treat adult patients with active LN in 2021. A decision on marketing authorisation in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorisation application was submitted to the Swiss Agency for Therapeutic Products and is currently under review.