Otsuka receives positive CHMP opinion for lupus nephritis treatment
pharmafile | July 22, 2022 | News story | Medical Communications |
The CHMP has 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 lupus nephritis (LN).
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 of those with SLE are at risk of developing LN during their lifetime, which has been suggested to cause irreversible nephron loss.
Voclosporin is an oral calcineurin inhibitor (CNI) for the treatment of LN secondary SLE. It has a postulated dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production, and promoting podocyte stability in the kidney.
“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 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 III AURORA 1 study, and the recent AURORA 2 continuation study. This opinion will now be reviewed by the EC, which has the authority to approve medicines for EU member states.
Lina Adams
