Otsuka Pharmaceutical Europe (Otsuka) and Aurinia Pharmaceuticals (Aurinia) have received approval from the European Commission (EC) for Lupkynis (voclosporin) for use in combination with mycophenolate mofetil for the treatment of lupus nephritis (LN).
The treatment approval is specifically for adult patients with active class 3, 4 or 5 – including mixed class 3/5 and 4/5 – LN and covers all 27 EU member states as well as Northern Ireland, Iceland, Norway and Liechtenstein.
Voclosporin is a drug developed by Aurinia for the treatment of LN secondary to systemic lupus erythematosus (SLE).
The decision is based on the positive results from the pivotal phase 3 AURORA 1 study and the AURORA 2 continuation study, which showed that treatment of LN with Lupkynis, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, proved to be statistically superior in complete renal response rates at 52 weeks, compared to MMF and low-dose corticosteroids alone.
In addition, the safety profile of Lupkynis and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
The approval makes Lupkynis the first oral treatment to be available in Europe for the treatment of active LN in adult patients.
Commenting on the announcement, Andy Hodge, chief executive officer of Otsuka, said: “Today’s EC approval of voclosporin represents a significant development for lupus nephritis patients in Europe, offering the appropriate patients a new treatment option.”
LN is a severe manifestation the chronic and debilitating autoimmune disease SLE, which is believed to cause irreversible nephron loss.
Up to 210 in 100,000 people in Europe live with SLE and, although the condition is more prevalent in women, men who develop SLE can be prone to a more severe form of the disease. Between 40-60% – depending on ancestry – of those with SLE are at risk of developing LN during their lifetime.
In 2021, the US Food and Drug Administration (FDA) granted approval of Lupkynis in combination with a background immunosuppressive therapy regimen, marking the first FDA-approved oral medicine to treat adult patients with active LN.
It is anticipated that the UK Medicines and Healthcare products Regulatory Agency will issue a decision on a marketing authorisation for the treatment in the coming weeks.
Otsuka initiated a partnership and licensing agreement with Aurinia in December 2020 for the development and commercialisation of Lupkynis for the treatment of LN in the EU, the UK, Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
The partnership leverages Otsuka’s expertise in rare kidney diseases to underscore Aurinia’s commitment to expanding global access to voclosporin for the treatment of LN.
Otsuka filed an initial marketing authorisation application (MAA) to the European Medicines Agency (EMA) voclosporin, as a treatment for LN patients.