NEW YORK, NY. July 22. The Lupus Research Alliance congratulates Aurinia Pharmaceuticals Inc. on acceptance of its NDA filing and priority review designation by the U.S. Food and Drug Administration for its investigational drug voclosporin for lupus nephritis. A serious inflammation of the kidneys, lupus nephritis is one of the most common complications of systemic lupus erythematosus. Currently, there are no FDA-approved treatments for lupus nephritis.
The FDA grants priority review designation to the evaluation of drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment for serious conditions. Under this designation, the Agency sets a goal to review and act upon the application within six months; in contrast, standard review can take ten months. The company anticipates having a decision from the FDA by early 2021.
“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.”
Key Lupus Nephritis Statistics from the National Institutes of Health:
- About 10-30% of people with lupus nephritis develop kidney failure.
- African Americans, Hispanics/Latinos, and Asian Americans are more likely to develop lupus nephritis than Caucasians.
- Lupus nephritis is more common in men than in women.
- Eight of 10 children with lupus will develop kidney disease.
Click here for press release from Aurinia Pharmaceuticals.
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus.