Actemra Gains New Indication for Systemic Sclerosis-Associated Interstitial Lung Disease
The FDA has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in SSc-ILD.
Immune Disorders
Ruxolitinib Gets Priority Review for Chronic Graft-vs-Host Disease
The sNDA submission is based on data from the multicenter, randomized, open-label phase 3 REACH3 study.
Avacopan Noninferior to Prednisone for ANCA-Associated Vasculitis
Avacopan noninferior to prednisone taper for remission at week 26, superior to prednisone taper for sustained remission at week 52
Lupkynis Approved for Active Lupus Nephritis
The approval was based on data from the pivotal phase 3 AURORA and phase 2 AURA-LV studies.
Locally-Delivered Sitaxsentan Designated Orphan Drug for Systemic Sclerosis
TMB-003 is a locally delivered formulation of sitaxsentan, a highly selective endothelin receptor antagonist.
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.
Belimumab Approved for Lupus Nephritis
Belimumab is already indicated for the treatment of active, autoantibody-positive systemic lupus erythematosus in individuals aged 5 years and over.
Orladeyo Now Available for Hereditary Angioedema
The oral, once-daily treatment will be shipped to patients with a prescription by specialty pharmacy Optime Care, Inc.
No Benefit With Ruxolitinib for COVID-19 Associated Cytokine Storm
The global, double-blind, placebo-controlled RUXCOVID study compared ruxolitinib to placebo, in addition to standard of care, in 432 patients aged 12 years and older with COVID-19 associated cytokine storm.
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.
