News

Dapirolizumab pegol eases SLE disease activity in Phase 3 trial

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…

Anti-TFAM antibodies linked to blood clot risk in SLE, study finds

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…

Obinutuzumab up for approval as lupus nephritis treatment in US

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…

FDA grants ADI-001 fast track status for treatment-resistant SLE

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…

Cell therapy SC291 gets FDA fast track designation for SLE

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…

Lupkynis approved in Japan to treat lupus nephritis

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…