News

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…

FDA grants fast track designation to CAR T-cell therapy for SLE

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…

Clinical trial of NKX019, cell therapy for lupus nephritis, opens

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,…

Disease remission achieved in SLE with dual-target CAR T-cell therapy

Nearly all people with systemic lupus erythematosus (SLE) treated with iCell Gene Therapeutics’ dual-target CAR T-cell therapy achieved medication-free disease remission, according to long-term follow-up data from a small Phase 1 trial. Further, kidney function continued to improve among those with lupus nephritis (LN), a common SLE complication…

Mutations increasing TLR7 activity may be lupus cause: Study

Mutations in the UNC93B1 gene — which produces a protein involved in the regulation of certain immune proteins, called toll-like receptors, or TLRs — may drive autoimmunity in people with lupus and other autoimmune conditions, according to a new study into the genetic cause of lupus and related diseases.

Stopping glucocorticoid therapy not tied to flare-up risk, data show

Discontinuing glucocorticoid therapy after achieving remission did not increase the risk of symptom flare-ups in people with systemic lupus erythematosus (SLE). That’s according to data presented at the 2024 European Alliance of Associations for Rheumatology (EULAR) congress, as announced in a EULAR press release. Data also showed that…