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FDA Alerts
Hematology
Lupus Nephritis
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FDA approves first oral therapy for lupus nephritis

Posted on January 24, 2021

The U.S. Food and Drug Administration has approved voclosporin (Lupkynis; Aurinia Pharmaceuticals) in combination with a background immunosuppressive therapy regimen for the treatment of adults with active lupus nephritis (LN), according to a press release. This is the first FDA-approved oral therapy for LN.

In clinical trials, a combination of voclosporin and standard-of-care was found to be more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients receiving standard-of-care alone.

“The Lupkynis approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals in the press release. “The approved label supports the efficacy and safety of Lupkynis as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of Lupkynis.”

Read the full press release here.

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