First lupus nephritis (LN) drug! New best-in-class calcium-toned neurophosphospresse inhibitor voclosporin is available in the United States!

May 27, 2020 /
PRNewswire
BIOON/ -- Aurinia Pharma is a biopharmaceutical company dedicated to developing innovative treatments for kidney disease andautoimmunediseasesRecently, the company announced that it has completed a rolling filing with the U.SFood and Drug Administration (FDA) for a new drug application (NDA) for voclosporin for lupus nephritis (LN)Previously, the FDA had granted voclosporin fast-track eligibility (FTD) for the treatment of LNThe NDA submission includes a priority review request that, if granted, would reduce the review period for the NDA from theFDAto eight months from the date of submission, compared with a standard review time of 12 monthslupus nephritis (LN) is aautoimmunedisease - systemiclupus(SLE) caused by severe renal inflammation, representing a serious progression in SLE, if not effectively controlled, can lead to permanent, irreversible tissue damage in the kidneys, leading to end-stage kidney disease (ESRD), life-threateningCurrently, there are no LN treatments approved FDA voclosporin has the potential to become a The FDA approved the first drug to treat lupus nephritis (LN) ndA of the drug, supported by a wide range of clinical development projects, including the Critical Phase III AURORA Study and the Critical Phase II AURALV Study Peter Greenleaf, President and CEO of Aurinia, said: "Lupus nephritis is a serious and debilitating consequence of lupus that can seriously affect the quality of life of individuals fighting lupus The Aurinia team continues to work hard to bring the first treatment approved by the FDA for LN patients, which is expected to change the course of LN Our extensive clinical programs, including the results of the AURA and AURORA trials, provide strong support for voclosporin as an innovative treatment for lupus nephritis, and we are rapidly advancing our U.S business strategy and infrastructure to support possible product launches early next year Lawrence Mandt, Senior Vice President for Quality and Regulatory Affairs, Aurinia, said: "Excellent Phase III clinical results enable the experienced Aurinia team to produce and submit a quality report for voclosporin before we expect it We now look forward to further dialogue with the FDA in the coming months on the date of acceptance and priority review and possible approval in early 2021 "
voclosporin structure (photo source: Aurinia ) Voclosporin is a research drug, a new and potentially best-in-class calcium-to-class calcium-to-sympathetic neurophosphatase inhibitor (CNI) with more than 2,600 clinical patient data on multiple indications Voclosporin is an immunosuppressant with a synergistic and dual mechanism Voclosporin stabilizes kidney foot cells (podocyte) by inhibiting calcium-toned neurophosphatase (CN), blocking the expression of IL-2 and the immune response mediated by T-cells Compared to traditional CNIs, voclosporin has more predictable pharmacokinetics and pharmacodynamic relationships (which may not require therapeutic drug monitoring), increased efficacy (compared to cyclosporina) and improved metabolic spectrum structurally, voclosporin is a similar to cyclosporine A, with an additional single-chain carbon extension with a double bond (ene bond) on the single carbon chain Voclosporin binds to cyclophilin protein A (cyclophilin A) to form an iso-polypolymer complex, which is combined and inhibits calcium phosphatase to perform immunosuppressive effects Voclosporin is equivalent to the binding affinity of cyclosporine A to human procycline protein, but voclosporin's enene bond side chain induces structural changes in calcium-toned phosphatase when combined, which may lead to enhanced immunosuppressive activity compared to cyclosporine A Aurinia expects that, under the Hatch-Wexman Act and other applicable laws, the patent protection of voclosporin in the United States and certain other major markets, including Europe and Japan, will be extended until at least October 2027, and the patent protection period for pediatric indications will be extended to April 2028, subject to regulatory approval In addition, if the
FDA to include the drug delivery program used in the AURA and AURORA trials in the product label, a U.S patent that covers the voclosporin dosage program will extend the warranty period of the product until December 2037 , Aurinia has successfully completed a Phase III clinical study (AURORA) on voclosporin's treatment of lupus nephritis In a global, placebo-controlled, critical Phase III study, data showed that voclosporin improved the near- and long-term prognosis in patients with lupus nephritis compared to placebo when combined with mycophenolic acid (MMF) and low-dose oral corticosteroids The specific data were that voclosporin significantly improved the rate of renal remission (main endpoint: 40.8% vs 22.5%, p0.001) compared to placebo, and also had a statistically significant improvement in all pre-specified stratification secondary endpoints In this study, the safety of the voclosporin scheme is comparable to the standard scheme in addition to lupus nephritis (LN), Aurinia is also developing voclosporin eye drops (VOSs) to treat dry eye disease (DES) Currently, there are three prescription drugs FDA approved for DES, two of which are CNI VOS has the potential to improve deS treatment by reducing the time it takes to achieve objective and subjective remission of DES symptoms and signs (BioValleyBioon.com) original source: Aurinia Completes Submission of New Drug apps
the slicing of the U.S Food and Drug Administration for The Treatment of Lupus Nephitis