The U.S. Food and Drug Administration (FDA) has granted fast track designation to RemeGen‘s RC18 (telitacicept) to treat people with systemic lupus erythematosus (SLE). A therapy candidate is put on the FDA’s fast track program if it can treat serious conditions and fill an unmet clinical need, either because no…
RemeGen has received $100 million in private financing to continue advancing RC18 (telitacicept), its lead treatment candidate for autoimmune diseases like systemic lupus erythematosus (SLE) now in a pivotal clinical trial. The funding will also support the China-based company’s early stage treatment discovery platform, help expand its manufacturing…
People with systemic lupus erythematosus (SLE) who have been in remission for at least a year and take low-dose prednisone as maintenance therapy have less risk of a disease relapse than those who stop taking it, a recent study suggests. The study, “Withdrawal of low-dose prednisone in…
Adding the experimental oral therapy voclosporin to standard treatment is safe, and its use more than doubles complete kidney responses in people with lupus nephritis, results from the Phase 3 AURORA study show. Aurinia Pharmaceuticals, the company developing voclosporin, plans to finish its rolling application to the U.S. Food…
The World Health Organization (WHO) is launching an international clinical trial to study the use of lupus treatments hydroxychloroquine and chloroquine as potential therapies for pneumonia caused by the new coronavirus. “This means that these drugs may be in high demand in the coming weeks,”…
A specific protein subunit — called GluN2A — found in a critical nerve cell receptor is the target of autoantibodies that cause neuron loss and cognitive difficulties in a mouse model of systemic lupus erythematosus (SLE), a study shows. Blocking GluN2A…
Aurinia Pharmaceuticals announced the start of a rolling submission of its application requesting that voclosporin be approved in the U.S. to treat people with lupus nephritis. In a rolling submission, completed portions of a New Drug Application (NDA) are submitted for review by the U.S. Food and Drug Administration…
PRV-3279, a potential therapy for people with systemic lupus erythematosus (SLE), durably blocks B-cells to prevent them from producing damaging antibodies, but does not deplete these key immune defense system cells, results from the first part of a Phase 1b/2 trial show. The Phase 1b portion of the PREVAIL study (…
Aurinia Pharmaceuticals is again partnering with the National Kidney Foundation (NFK) during National Kidney Month to raise awareness of lupus nephritis (LN) — a type of kidney disease caused by systemic lupus erythematosus, or lupus. A new program launched by Aurinia, called ALL IN, is an online…
Treatment with Acthar Gel (repository corticotropin injection) may ease exacerbations and symptoms in people with systemic lupus erythematosus (SLE) and other inflammatory disorders, a real-world study reports. About 95% of those with SLE showed benefits, as rated by physicians. The study, “…