Aurinia completes FDA new drug application for treatment of lupus nephritis

Aurinia Pharmaceuticals announced the completion of its voclosporin application to the U.SFood and Drug Administration for a new drug (NDA) as a potential treatment for lupus nephritis (LN), a severe kidney inflammation caused by the autoimmune disease lupus erythematosus (SLE)currently, LN does not have FDA-approved therapeutic drugsNDA submissions include a priority review of the application for voclosporin, which, if approved, reduces the FDA's review of NDA from the date of submission to eight months, compared with a standard review time of 12 monthsVoclosporin is a new type of calcium-toned neurophosphatease inhibitor (CNI) that blocks IL-2 expression and T-cell-mediated immune responses and stabilizes foot cells in the kidneys by inhibiting calcium-toned neurophosphataseCompared to traditional CNI, it has a more predictable pharmacokinetic and pharmacodynamic relationship (which may not require therapeutic drug monitoring), enhanced efficacy (as opposed to cyclosporine A) and higher metabolic propertieslupus nephritis is caused by systemic lupus erythematosus caused by kidney inflammation, which represents severe SLE progressionSLE is a chronic, complex and often disabling diseaseKidney damage in LN patients leads to proteinuria/blood urine, decreased kidney function, and if poorly controlled, LN can lead to permanent and irreversible tissue damage to the kidneys, leading to end-stage kidney diseasePeter Greenleaf, President and CEO of Aurinia, said: 'Our extensive clinical program, including the results of the critical Phase 3 AURORA study and The 2 ThaURA LV study, provides strong support for Voclosporin as a new treatment for lupus nephritis, and we are rapidly advancing our U.Sbusiness strategy and infrastructure to support its rapid market launch'