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.
Immune Disorders
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.
Voclosporin NDA for Lupus Nephritis Submitted to FDA
The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
Trial Evaluating Ruxolitinib for COVID-19 Associated Cytokine Storm Initiated
A phase 3 trial evaluating ruxolitinib (Jakafi; Incyte) for the treatment of coronavirus disease 2019 (COVID-19)-associated cytokine storm is being initiated in patients 12 years of age and older.
Telitacicept Fast-Tracked for Systemic Lupus Erythematosus
The FDA has granted Fast Track designation to telitacicept (RC18; RemeGen) for the treatment of systemic lupus erythematosus.
Patient’s Death Leads to Lawsuit After Physician Fails to Check Creatinine Level Before Infusing Drug
The month’s case involves a lawsuit against 2 healthcare professionals, a primary care physician and a rheumatologist. The patient, Mrs X, was a postmenopausal woman in her early 50’s. The mother of 3 adult children who had successfully worked for 15 years until her scleroderma made it increasingly difficult to type on a computer.
Remestemcel-L Under Review for Steroid-Refractory Acute Graft Versus Host Disease
The FDA has accepted for Priority Review the Biologics License Application for remestemcel-L (RyoncilTM; Mesoblast Limited) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
FDA: Insulin Among Drugs Transitioned to Biological Products
New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions.
