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.
Miscellaneous Immune Disorders
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.
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.
FDA: Insulin Among Drugs Transitioned to Biological Products
New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions.
Anifrolumab Improves Response at 52 Weeks in Lupus
Rate of composite response showing reduced disease activity higher with anifrolumab versus placebo
Belimumab Associated With Meaningful Improvement in Lupus Nephritis Trial
GlaxoSmithKline announced positive results from the phase 3 BLISS-LN trial of belimumab for the treatment of active lupus nephritis in adult patients.
Xembify Now Available for Primary Humoral Immunodeficiency
Xembify (immune globulin subcutaneous, human- klhw), a 20% immune globulin solution has been made available by Grifols.
Itolizumab Receives Fast Track Status for Lupus Nephritis
The FDA has granted Fast Track designation for itolizumab (EQ001; Equillium) for the treatment of lupus nephritis.
Palmoplantar Pustulosis Confirmed as Orphan Disease
However, psoriasis frequently co-occurs in patients with palmoplantar pustulosis.
Mepolizumab Reduces Flares in Patients With Hypereosinophilic Syndrome
GlaxoSmithKline announced positive results from the pivotal phase 3 study of mepolizumab in the treatment of patients with hypereosinophilic syndrome (HES). HES is a rare group of inflammatory disorders characterized by persistent eosinophilia that can potentially lead to inflammation, organ damage, and possibly death if left untreated. The 32-week, double-blind, placebo-controlled phase 3 study evaluated…
