CABA-201, an experimental cell therapy for lupus and other autoimmune disorders, has been granted fast track status by the U.S. Food and Drug Administration (FDA). The FDA awards this designation to therapies with the potential to address unmet medical needs in the treatment of serious conditions. Fast track status…
Lupkynis (voclosporin) is now approved in Switzerland to treat adults with active lupus nephritis, a complication of lupus characterized by kidney damage and inflammation. The approval specifically covers the treatment, given along immunosuppressants, for adults with active class 3, 4, and 5 lupus nephritis — three subtypes of the…
The Lupus Foundation of America (LFA) is calling on the community to help increase visibility and promote education about the autoimmune disease throughout the month of May — thereby marking Lupus Awareness Month. “All too often people with lupus hear that they don’t ‘look’ sick. This is why…
The Lupus Research Alliance (LRA) is funding four research projects aiming to explore molecular targets that could lead new ways of treating lupus. The grants were given as part of the LRA’s Lupus Mechanisms and Targets Award (LMTA) program, which offers up to $600,000 over three years…
Treatment with upadacitinib led to a significant reduction in disease activity for people with moderate-to-severe systemic lupus erythematosus (SLE) in a Phase 2 clinical trial, according to top-line results announced by its developer, AbbVie. Based on these positive results, AbbVie now is planning to advance upadacitinib to Phase 3 clinical…
An enzyme called fumarate hydratase is involved in the control of the inflammatory activity of macrophages, a type of immune cell with a central role in driving inflammatory disorders like lupus, researchers report. “No-one has made a link from Fumarate Hydratase to inflammatory macrophages before and we feel that…
New measures are needed to assess disease severity in lupus in clinical trials, a study highlights. One important goal in developing such measures is to include patient-reported outcomes — which, according to the study authors, are now not used in most clinical trials assessing the effectiveness of new treatments.
A urine test that can be performed at home showed good accuracy in detecting lupus nephritis, a form of lupus marked by kidney damage, in a recent study. This test, which works with a smartphone app, “could potentially accelerate early detection of renal involvement or disease flares in lupus patients,…
The U.S. Patent and Trademark Office (USPTO) has allowed Aurinia Pharmaceuticals submit a new patented method of using Lupkynis (voclosporin), its approved oral treatment for lupus nephritis. The new application (No. 17/713,140), titled, “Improved Protocol for Treatment of Lupus Nephritis,” covers a method of using Lupkynis in combination with…
The approvals of new medications in the last few years have dramatically shifted the treatment landscape for lupus nephritis, a severe manifestation of lupus characterized by kidney inflammation, with a sharp drop found in the use of rituximab. That’s according to the market research group Spherix Global Insights,…