Voclosporin for Lupus Nephritis Under ‘Rolling’ Review by FDA

Voclosporin for Lupus Nephritis Under ‘Rolling’ Review by FDA
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Aurinia Pharmaceuticals announced the start of a rolling submission of its application requesting that voclosporin be approved in the U.S. to treat people with lupus nephritis.

In a rolling submission, completed portions of a New Drug Application (NDA) are submitted for review by the U.S. Food and Drug Administration (FDA) on an ongoing basis.

Aurinia expects to finish submitting the application by midyear, potentially allowing for a regulatory decision in 2021. The company said the application’s “nonclinical module,” which primarily deals with safety and pharmacological information, is finished.

“Following a positive … meeting with the FDA in February, we are pleased to initiate our rolling NDA submission to the Agency, a critical step toward making voclosporin available to patients as soon as possible,” Larry Mandt, senior vice president of quality and regulatory affairs at Aurinia, said in a press release.

“We look forward to working with the FDA throughout the process,” added Mandt.

The start of a submission process follows results from the AURORA Phase 3 study (NCT03021499), which showed that adding voclosporin to standard care nearly doubled the proportion of lupus nephritis patients achieving complete kidney responses.

Data from a previous Phase 2b trial (NCT02141672) also showed positive results in people with this form of kidney inflammation.

Another Phase 2 trial (NCT02949973), called AURION, evaluated biomarkers that can be used to identify patients most likely to benefit from voclosporin’s use. Results found that C3 and C4 — two members of the complement system, a set of blood proteins that participate in immune protection — and the urinary protein creatinine ratio helped to predict treatment responses. Creatinine is a waste product of muscles and an indicator of kidney function.

Findings from all these trials also supported treatment with voclosporin as safe and well-tolerated.

Voclosporin is an immunosuppressant. Immune system agents called T cells are recruited by an enzyme called calcineurin. Voclosporin is a small molecule that’s designed to bind to calcineurin to prevent the activation of T-cells, ease inflammation, and stop further damage to podocytes — specialized kidney cells important in blood filtration.

The FDA placed voclosporin on fast track development in 2016 to advance it as a potential treatment of lupus nephritis.

David earned a PhD in Biological Sciences from Columbia University in New York, NY, where he studied how Drosophila ovarian adult stem cells respond to cell signaling pathway manipulations. This work helped to redefine the organizational principles underlying adult stem cell growth models. He is currently a Science Writer, as part of the BioNews Services writing team.
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José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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David earned a PhD in Biological Sciences from Columbia University in New York, NY, where he studied how Drosophila ovarian adult stem cells respond to cell signaling pathway manipulations. This work helped to redefine the organizational principles underlying adult stem cell growth models. He is currently a Science Writer, as part of the BioNews Services writing team.
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