News

NKF launches educational video series for lupus, lupus nephritis

The National Kidney Foundation (NFK) has launched a patient-friendly video series to help patients better understand the association between lupus and lupus nephritis. Marked by kidney inflammation and damage, lupus nephritis is considered to be one of the most severe complications of lupus, since it may compromise the…

Off-the-shelf CAR cell therapy to enter SLE trial next year

The U.S. Food and Drug Administration (FDA) has cleared Century Therapeutics to start a Phase 1 clinical trial that will test its off-the-shelf cell therapy CNTY-101 in people with systemic lupus erythematosus (SLE). The Phase 1 study will enroll people with moderate to severe SLE who’ve failed to respond…

Phase 1/2 Trial of GC012F in hard-to-treat SLE expected by 2024

The U.S. Food and Drug Administration (FDA) has given Gracell Biotechnologies the green light to start a Phase 1/2 clinical trial to test its experimental cell therapy GC012F in people with difficult-to-treat systemic lupus erythematosus (SLE). The study’s Phase 1 portion should start in 2024 to assess the safety,…

Specific autoantibodies can raise cardiovascular disease risk with SLE

Certain self-reactive antibodies, called antiphospholipid antibodies (aPLs), significantly increase the risk of a heart attack, stroke, or other cardiovascular event in people with systemic lupus erythematosus (SLE), a study shows. Among aPLS, “we identified that [anticardiolipin antibodies] and lupus anticoagulant positivity are independently associated with [cardiovascular disease], after adjusting…

Otsuka seeks approval in Japan of Lupkynis for lupus nephritis

Otsuka Pharmaceutical is seeking approval in Japan to manufacture and market Lupkynis (voclosporin) for the treatment of lupus nephritis, a kidney complication of systemic lupus erythematosus (SLE). The new drug application filed by Otsuka will be reviewed and decided upon by the Japanese Ministry of Health, Labour,…