First lupus nephritis (LN) drug! The new best-in-class calcium-modulating neurophosphatase inhibitor voclosporin has been reviewed by the FDA!

New Year's Day is a biopharmaceutical company dedicated to the development of innovative therapies for kidney disease and autoimmune diseasesThe company recently announced that the U.SFood and Drug Administration () has accepted applications for new drugs () for the treatment of lupus nephritis () and granted priority review of prescription drug user charges () target action date satIt was also informed that the company did not intend to convene an advisory committee meeting to discuss the matter at this timeFast Track Eligibility for Treatment has previously been granted ()Lupus nephritis ( ) is a severe renal inflammation caused by autoimmune disease systemic lupus () represents serious progress ionizing progression that can lead to permanent and irreversible tissue damage in the kidneys leading to end-stage renal disease ( )There are currently no approved treatmentsIf approved there is potential to become the first approved drug to treat lupus nephritis ()The drug is based on a wide range of clinical development projects supported by key phase studies and critical period studiesA global, placebo-controlled, critical-period study shows improved short-term and long-term prognosis for patients with lupus nephritis compared to placebo when combined with mycophenolic acid () and low-dose oral corticosteroidsThe specific data were: significantly improved the rate of renal remission (primary endpoint: ) compared to placebo, and also statistically significant lying at all pre-specified stratified secondary endpointsThe safety and standard scheme of the scheme in this study are comparableStructure (Picture Source: Company) is a research drug which is a new, potentially best-in-class () calcium-modulating neurophosphosase inhibitor () with clinical data on multiple indications than in patientsIt is an immune inhibitor with a synergistic and dual mechanismStabilize the kidney foot cells by inhibiting the blocked expression of calcium-modulating neurophosphatase () and the cell-mediated immune response ()There are more predictable pharmacokinetics and pharmacodynamic relationships (possibly no therapeutic drug monitoring), increased efficacy (compared to cyclosporine) and metabolic spectrum improvements compared to traditional onesA similarie that is structurally cyclosporine ( ) has an additional single-stranded carbon extension on the single carbon chain with a double bond (ene bond)Combined with procycline protein ( ) to form isopting complex and inhibiting calcium-modulating phosphatase to play an immunosuppressive roleThe binding affinity of cyclosporine to human procycline protein is comparable but the olebond side chain can induce structural changes in calcium-modulating phosphatase when combined which may lead to enhanced immunosuppressive activity compared to cyclosporineIn addition to lupus nephritis () the company is also developing eye drops () for the treatment of dry eye disease ()There are currently a variety of approved treatments for prescription drugsThere is potential for improved treatment by reducing the time to achieve objective and subjective remission of symptoms and signs() Source: