The U.S. Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) as an add-on treatment for adults with lupus nephritis, a form of lupus marked by kidney damage. “The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for…
A single infusion of the experimental cell therapy ADI-001 led to reductions in disease activity for seven lupus patients in a clinical trial, according to preliminary data announced by its developer Adicet Bio. No serious side effects reported. “These preliminary results reinforce our belief that ADI-001 has the…
A self-administered, under-the-skin injection version of AstraZeneca’s Saphnelo (anifrolumab-fnia) was effective for reducing disease severity in adults with systemic lupus erythematosus (SLE), according to results from an interim analysis of a Phase 3 clinical trial. “Today’s news takes us one step closer in making the clinically meaningful…
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…