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.
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.
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