FDA to Review Avacopan for ANCA-Associated Vasculitis
Avacopan is an orally-administered, small molecule designed to selectively block the complement 5a receptor on destructive inflammatory cells such as blood neutrophils.
Immune Disorders
Newly Diagnosed Lupus Erythematosus Could Potentially Be Drug Induced
A new case of cutaneous lupus erythematosus or systemic lupus erythematosus could potentially be drug induced.
Inolimomab BLA Submitted for Graft Versus Host Disease
The BLA submission includes data from a phase 3 study comparing inolimomab to antithymocyte globulin in 100 adults with steroid-refractory aGvHD.
MPR Weekly Dose Podcast Episode 44
This week: The government makes a $1.95 billion deal for a COVID-19 vaccine; Promising data from the Oxford vaccine trial; The CDC retakes control of COVID-19 data; Novel calcineurin inhibitor for lupus nephritis gets priority review; And there’s new treatment for narcolepsy.
Voclosporin Granted Priority Review for Lupus Nephritis
The FDA will give Priority Review to the New Drug Application (NDA) of voclosporin (Aurinia Pharmaceuticals) for the treatment of lupus nephritis.
Avacopan NDA Submitted for ANCA-Associated Vasculitis
ChemoCentryx, Inc has submitted a NDA to the Food and Drug Administration (FDA) for acavopan in the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Trial Investigating Ustekinumab for Systemic Lupus Erythematosus Discontinued
Janssen has decided to discontinue the phase 3 LOTUS study evaluating ustekinumab (Stelara®) for the treatment of systemic lupus erythematosus.
Tacrolimus Inhalation Powder Gets Orphan Drug Status for Organ Rejection Prophylaxis
The FDA has granted Orphan Drug Designation to Tacrolimus Inhalation Powder (TFF Pharmaceuticals) for prophylaxis of lung allograft rejection.
Long-Term Rituximab May Aid in Antibody-Associated Vasculitis
Relapse rates lower versus placebo in granulomatosis with polyangiitis, microscopic polyangiitis.
FDA Grants Orphan Drug Status to Antifibrotic Therapy for Systemic Sclerosis
TLY012, a PEGylated recombinant human TRAIL (TNF-related apoptosis-inducing ligand) protein, binds upregulated death receptor 5 (DR5) on myofibroblasts (MFBs) and selectively blocks activation of MFBs in fibrotic regions.
