Potential best-in-class! Aurinia lupus nephritis new drug in the United States to start NDA rolling submission.

Aurinia Pharma is a late-clinical Canadian biopharmaceutical company dedicated to the research, development and commercialization of new drugs in the field of kidney and autoimmune diseases.
, the company announced that it has initiated a rolling application for a new drug (NDA) for voclosporin to the FDA for lupus nephritis (LN).
rolling submission allows drug companies to submit completed parts of the NDA to the FDA for review, rather than waiting for each part to be completed before reviewing the entire NDA.
LN is a severe advance in the kidneys caused by systemic lupus erythematosus (SLE), which, if left unchecked, can lead to permanent and irreversible tissue damage in the kidneys, leading to end-stage kidney disease, which is life-threatening.
Voclosporin is a new, new generation calcium-modulating neurophosphatase inhibitor (CNI), has the potential to become the best-in-class CNI, the drug is an immunosuppressant class, with synergistic and dual action mechanism, by inhibiting calcium-modulating neurophosphosase, can block the expression of IL-2 and T-cell-mediated immune response, stable kidney foot cells.
voclosporin has a more predictable pharmacokinetic and pharmacodynamic relationship (may not require therapeutic drug monitoring), increased efficacy (compared to cyclosporine), and improved metabolic spectrum than traditional CNI.
structurally, voclosporin is an analogue of cyclosporina A with an additional single-stranded carbon extension with a double bond (ene bond) on the single carbon chain.
Voclosporin combines with procycline a to form an iso-dipolymer complex, which in turn binds and inhibits calcium-modulating phosphatase to play an immunosuppressive role.
Voclosporin and cyclosporin a have the same affinity for human procycline protein, but voclosporin's oleoid side chain induces structural changes in calcium-modulating phosphatase when combined, which may lead to enhanced immunosuppressive activity compared to cyclosporin a.
in U.S. regulation, the FDA granted voclosporin fast-track access to lupus nephritis in 2016.
fast-track eligibility for experimental drugs means that pharmaceutical companies can interact more frequently with the FDA during the development phase, are eligible for accelerated approval and priority review if they meet the relevant criteria after submitting a listing application, and are also eligible for rolling reviews.
in a successful global, placebo-controlled, critical Phase III AURORA study, voclosporin improved the immediate and long-term prognosis of patients with lupus nephritis compared to placebos when combined with mercophenolite (MMF) and low-dose oral corticosteroids.
specifically, voclosporin significantly improved the renal remission rate (main endpoint: 40.8% vs 22.5%, p 0.001) and also showed a statistically significant improvement in all pre-specified graded secondary endpoints.
security, the voclosporin scheme is comparable to the standard scheme.
currently, Aurinia has submitted non-clinical modules in voclosporin's NDA for lupus nephritis treatment, and expects to complete the submission of all modules by the end of the second quarter of 2020.
the company has planned to apply to the FDA for a priority review of voclosporin after it is completed.
in addition to lupus nephritis, Aurinia is also developing voclosporin for the treatment of celisay globulin, and voclosporin eye drops for the treatment of dry eye disease.
Reference Source: Aurinia Pharmaceuticals Rolling Sorbys Rolling Submissions a New Drug Application to the U.S. Food and Drug Administration for Voclosporin in The Treatment of Lupus Nephritis.