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…
An associate professor of biomedical engineering at the University of Houston is developing a new way to deliver treatments for lupus directly to the spleen, which is the home of certain immune cells thought to drive the disease’s progression. Tianfu Wu, PhD, is working on an experimental approach that…
The U.S. Food and Drug Administration (FDA) has approved Benlysta (belimumab) in an autoinjector that can be used at home as an add-on treatment for children ages 5 and older with active lupus nephritis, a serious complication of lupus that causes inflammation and damage to the kidneys. This…
One year of treatment with dapirolizumab pegol can reduce fatigue and ease disease activity in people with systemic lupus erythematosus (SLE), according to new results from a Phase 3 clinical trial. Findings from the trial, called PHOENYCS GO (NCT04294667), were shared by UCB and Biogen, the two companies developing…
People with systemic lupus erythematosus (SLE) who have antibodies that target the mitochondrial transcription factor A (TFAM) protein are more likely to develop certain blood clotting complications, a study found. The antibodies were a risk factor for blood clots, or thrombotic events, even when accounting for other factors that…
May is Lupus Awareness Month, and the Lupus Foundation of America is calling on supporters to join efforts to bring attention to lupus, an autoimmune disease whose symptoms are not always readily apparent. The focus of this year’s awareness month is “Make Lupus Visible” — given that the…
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 agreed to review an application by Roche seeking approval of obinutuzumab for the treatment of lupus nephritis, a lupus complication marked by kidney inflammation and damage. Developed by Roche’s subsidiary Genentech and Biogen, obinutuzumab is an antibody-based treatment, already…