Author Archives: Marisa Wexler, MS

CAR T-cell therapy IMPT-514 gets FDA fast track designation for lupus

The U.S. Food and Drug Administration (FDA) has granted fast track designation to IMPT-514, a CAR T-cell therapy being developed by Immpact Bio for people with active, treatment-resistant lupus nephritis and systemic lupus erythematosus (SLE). Lupus nephritis is a serious complication of lupus characterized by kidney inflammation.

Greater use of Benlysta, Saphnelo seen in US, EU to treat lupus

In both the U.S. and Europe, clinicians want to limit treatment with glucocorticoids — steroid hormones whose long-term use for autoimmune diseases is tied to serious side effects — among people with moderate to severe lupus. To that end, healthcare professionals are increasingly prescribing biological therapies like Benlysta…

Phase 2 trial of GLPG3667 for SLE now recruiting patients in US

Galapagos officially has launched a Phase 2 clinical trial that will test its oral therapy GLPG3667 — designed to ease disease severity in people with systemic lupus erythematosus (SLE) — at a half dozen sites in the U.S. The first participant has been randomized, or assigned to a treatment…

Phase 3 trials of ianalumab for SLE, lupus nephritis now enrolling

Three new Phase 3 clinical trials testing the experimental therapy ianalumab in people with systemic lupus erythematosus (SLE) and lupus nephritis are now recruiting patients. All three trials are being sponsored by Novartis, the company developing ianalumab. Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance,…

Lupkynis approved in Switzerland to treat adults with lupus nephritis

Lupkynis (voclosporin) is now approved in Switzerland to treat adults with active lupus nephritis, a complication of lupus characterized by kidney damage and inflammation. The approval specifically covers the treatment, given along immunosuppressants, for adults with active class 3, 4, and 5 lupus nephritis — three subtypes of the…