Aurinia Pharma Gets Positive CHMP Opinion For LUPKYNIS For Active Lupus Nephritis Treatment

(RTTNews) - Aurinia Pharmaceuticals Inc. (AUPH) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency adopted a positive opinion recommending voclosporin (brand name, LUPKYNIS) for marketing authorization to treat adults with active lupus nephritis, a serious complication of systemic lupus erythematosus or SLE.

Based on the CHMP recommendation, a decision by the European Commission is expected in approximately two months. If granted by the European Commission, the centralized marketing authorization would be valid in all EU member states as well as in Iceland, Liechtenstein, and Norway.

Lupus nephritis is a serious manifestation of systemic lupus erythematosus, a chronic and complex autoimmune disease.

The U.S. Food and Drug Administration approved LUPKYNIS (voclosporin) on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.

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