The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to FT819, a cell therapy Fate Therapeutics is developing to treat lupus. An RMAT designation is awarded to treatments for serious conditions that have shown promise in early clinical testing. Designed to speed…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to experimental cell therapy SC291 as a potential treatment for hard-to-manage systemic lupus erythematosus (SLE). Fast track status is given to therapies that have the potential to improve care for serious diseases, with the goal of…
Treatment with dapirolizumab pegol is better than a placebo at controlling disease activity in people with systemic lupus erythematosus (SLE), according to new results from a Phase 3 clinical trial. UCB and Biogen, the therapy’s developers, shared full results from that trial — which they called “statistically…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to CAR T-cell therapy ADI-001 as a potential treatment for lupus nephritis, a lupus complication marked by kidney damage and inflammation. The FDA gives fast track status to experimental treatments that have the potential to fill unmet…
The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is joining the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to focus on CAR T-cell treatments and other engineered cell therapies, a promising new therapeutic field now being explored for lupus. “We are delighted to have…
Treatment with the investigational injection therapy itolizumab significantly reduced urine protein levels, a marker of kidney dysfunction, in people with active lupus nephritis, a serious lupus complication marked by kidney damage and inflammation. That’s according to top-line results from a Phase 1b trial called EQUALISE (NCT04128579) that were…
An arm of China’s National Medical Products Administration has given Kezar Life Sciences the green light to open sites in China for a Phase 2 clinical trial testing zetomipzomib in people with lupus nephritis, a severe complication of lupus characterized by kidney inflammation and damage. Kezar will run…
The first participant has been treated in a Phase 1 clinical trial testing the CAR T-cell therapy CC-97540 (BMS-986353) in people with severe systemic lupus erythematosus (SLE). “The opportunity to provide lupus patients with access to this treatment, all while ensuring they receive the highest level of care, is…
The antimalarial agent hydroxychloroquine doesn’t appear to lower the risk of preeclampsia during pregnancy in women with lupus, a study reports. The study, “Hydroxychloroquine in lupus pregnancy and risk of preeclampsia,” was published in Arthritis & Rheumatology. Preeclampsia is a pregnancy complication marked by high…
Scientists have created small molecules that can block the activity of SLC15A4, an inflammatory protein — long considered undruggable — that’s known to play a central role in driving lupus and other autoimmune diseases. Further, the team showed that these molecules could reduce inflammation in lupus patient cells and…