LRA Applauds Aurinia on Priority Review of Voclosporin by U.S. FDA for Lupus Nephritis
Great news from the Lupus Research Alliance came out this week and we had to share it with you all. The U.S. Food and Drug Administration recently accepted the New Drug Application and granted priority review designation to Aurinia Pharmaceuticals Inc. for its investigational drug voclosporin as a treatment for lupus nephritis – inflammation of the kidneys.
“If approved by the FDA, voclosporin would be the first treatment approved specifically for this devastating complication that affects up to half of the five million people worldwide with lupus,” noted Lupus Research Alliance President and CEO Kenneth M. Farber. “Lupus nephritis can cause irreparable damage to the kidneys that requires dialysis or an organ transplant. A new treatment for lupus nephritis could dramatically change the lives of people with lupus.”
Under priority review designation, the FDA sets a goal to review and act upon the application within six months; in contrast, the standard review can take ten months. Aurinia anticipates having a decision from the FDA by early 2021. More to come from LRA as things progress. Stay tuned!