FDA Extends Expiration Date of Immunoglobulin Product Cutaquig
The new expiration date for cutaquig is valid for 42 existing lots that were manufactured and distributed in 2019 and 2020.
Miscellaneous Immune Disorders
Antifibrotic Therapy Gets Orphan Drug Status for Systemic Sclerosis
ACE-1334 is a TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands.
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.
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.
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.
