FDA approves Aurinia’s oral lupus nephritis therapy

pharmafile | January 26, 2021 | News story | Manufacturing and Production Aurinia 

The FDA has approved Aurinia Pharmaceuticals’ LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN).

The drug is the first FDA-approved oral therapy for LN, which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE).

LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the agency in 2016.

In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals, said: “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.

“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.”

Kathleen A Arntsen, President and CEO of Lupus and Allied Diseases Association, said: “As a patient-led organisation who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS.

“There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of colour.”

Darcy Jimenez

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