FDA approves first oral new drug for lupus nephritis

On January 22, Aurinia Pharmaceuticals announced FDA approval for Lupkynis (voclosporin, voloxysporin) to be listed as a combination immunosuppressive therapy for the treatment of adult active lupus nephritis (LN).
Lupkynis is the fda-approved first oral treatment for lupus nephritis.
cyclosporine is a cyclosporine-like substance with a 3-4-fold increase in structurally modified activity and faster removal of related metabolites, making the PK/PD relationship easier to predict.
also has the advantage of having a smaller effect on cholesterol and triglycerides and a lower risk of diabetes than cyclosporine.
In critical Phase III clinical trials, patients receiving Voclosporin Combined Standard Therapy (SoC) achieved full renal remission at week 52 almost twice as fast (40.8 percent vs 22.5 percent) as the standard therapy group, and the urinary protein creatinine ratio (UPCR) decreased twice as fast as the control group.
UPCR is a standard method for monitoring protein levels in the kidneys.
early intervention and kidney remission can improve long-term prognosm and prevent irreversible kidney damage. The most common adverse reactions in
were reduced cymbal filtration, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, indigestion, hair loss, renal insexia, abdominal pain, mouth ulcers, fatigue, tremors, acute kidney injury, and decreased appetite.
nephritis is one of the most serious complications of systemic lupus erythematosus (SLE), which, if poorly controlled, can lead to permanent and irreversible kidney damage, significantly increasing the risk of kidney failure, cardiovascular events and death.
200,000 to 300,000 SLE patients in the United States, one-third of whom had progressed to LN at the time of diagnosis.
Blacks and Asians with SLE were four times more likely to develop LN than Caucasians, and blacks and Hispanics with SLE tended to develop LN earlier and have poorer outcomes.
LN has been lacking effective therapeutic drugs.
December 17, 2020, GSK's new beliju mono-anti-adhesive disease was approved for LN patients undergoing standard therapy, the first FDA-approved drug to treat lupus nephritis.
cyclosporine is the first oral therapy approved by the FDA specifically for LN treatment.