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…
The U.S. Food and Drug Administration (FDA) has granted fast track status to ADI-001, Adicet Bio’s CAR T-cell therapy for systemic lupus erythematosus (SLE) that’s resistant to available treatments, the company announced in a press release. The designation follows the FDA’s award last year of fast track…
Caribou Biosciences has launched a Phase 1 clinical trial to evaluate the safety and efficacy of CB-010, its CAR T-cell therapy for lupus that affects the kidneys and other organs. CB-010 is being developed as a treatment for people with lupus nephritis, a common complication of lupus that…
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…