Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients.
The drug has received approval from the European Commission (EC) in combination with mycophenolate mofetil (MMF) 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 is based on positive results from the pivotal Phase III AURORA 1 study and the AURORA 2 continuation study, which demonstrated that treatment with voclosporin, 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 was comparable.
“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.
LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease that is suggested to cause irreversible nephron loss. Up to 210 in 100,000 people in Europe live with SLE and 40-60% of those are at risk of developing LN during their lifetime.
The combination treatment for this indication was approved by the US Food and Drug Administration in 2021 and gained a positive opinion from the CHMP earlier this year.
Otsuka entered a collaboration and licensing agreement in December 2020 with Aurinia Pharmaceuticals for the development and commercialisation of voclosporin for the treatment of LN in the EU, Japan, the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.