The European Medicines Agency (EMA) has given a positive opinion to a combination therapy for the treatment of adults with lupus nephritis (LN).
Otsuka Pharmaceutical Europe received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the use of its oral calcineurin inhibitor (CNI) 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).
Lupus nephritis is a chronic autoimmune disease which affects up 210 in 100,000 people in Europe1. The condition is a type of kidney disease during which the immune system targets its own body tissues. Symptoms include swelling of the limbs, high blood pressure, a frequent need to urinate and weight gain.
The positive CHMP opinion was based on results from Otsuka’s Phase III AURORA 1 study and its AURORA 2 continuation study. Results show 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 profile2.
“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”.
2: Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021;397:2070-2080.