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Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.
Otsuka Pharmaceutical Europe (Otsuka) announced on Sept. 20, 2022 that the European Commission (EC) has approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV, or V lupus nephritis (LN).
The EC decision applies to all 27 European Union member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. According to a company press release, voclosporin is the only oral treatment approved in Europe for the treatment of active LN in adult patients.
LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease, and is suggested to cause irreversible nephron loss. According to the press release, up to 210 in 100,000 people in Europe live with SLE, and between 40 and 60 percent of those with SLE are at risk of developing LN during their lifetime.
"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, Otsuka Pharmaceutical Europe, in the release.