Otsuka Pharmaceutical Europe Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion relating to the use of 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).
Key highlights:
- The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion relating to the use of Lupkynis, from Otsuka, for the treatment of adult patients with active class III, IV or V lupus nephritis (LN).
- Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease.
- The positive CHMP opinion is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study.
- The positive opinion from the CHMP will now be reviewed by the EC.
Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease. 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, which has been suggested to cause irreversible nephron loss.
“Lupus nephritis can have severe consequences if inadequately managed, which is why the positive recommendation received today is a significant milestone as we continue to work towards being able to offer this treatment option to patients,” said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. "We look forward to the outcome of the European Commission (EC) decision which, if positive, would make voclosporin the first oral medicine approved in the EU to treat active LN in adult patients”.
The positive CHMP opinion is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study. The results of the AURORA 1 study demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a generally comparable safety profile. The AURORA 2 study demonstrated long-term safety and tolerability of voclosporin with a generally similar safety profile and no unexpected safety signals compared to placebo (both taken in combination with MMF and low-dose oral steroids) in patients receiving treatment for an additional 24 months following their completion in the AURORA 1 study.
The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for EU member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. The EC has 67 days from the CHMP opinion to issue a final decision.