The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune disease. Lupkynis, previously granted Fast Track Designation, gained regulatory approval under Priority Review based on data from two Phase II studies conducted by Aurinia that demonstrated significant improvement in adult patients diagnosed with LN after one year.

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