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…
Lupkynis (voclosporin) is now approved in Japan to treat lupus nephritis, a complication of lupus marked by kidney damage and inflammation. The Japanese Ministry of Health, Labour, and Welfare approved the treatment’s use in combination with the immunosuppressant mycophenolate mofetil. Otsuka Pharmaceutical filed a new drug…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Caribou Biosciences‘ CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE) — the most common form of lupus — that’s resistant to available treatments, the company announced in a press release. This designation is…
The vast majority of people with systemic lupus erythematosus (SLE) experience musculoskeletal symptoms, marked by pain, ache, discomfort, and numbness, often in the joints, primarily the hands, wrists, and knees. That’s according to a study from researchers in Egypt, which also found that musculoskeletal symptoms were associated with a…
Patient screening is underway in a U.S.-based clinical trial of NKX019, an investigational natural killer (NK) cell therapy for people with treatment-resistant lupus nephritis, a serious complication of lupus, its developer, Nkarta, announced. The trial, called Ntrust-1, is a multicenter and open-label study to assess the safety,…
A number of former NFL players joined 2009 Super Bowl champ Willie Colon this past week for the 10th anniversary of a golf event that is anticipated to raise $450,000 this year for the Lupus Research Alliance (LRA) to support the fight against lupus. The annual Willie Colon…