Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
16/10/2026
US FDA approved Roche’s satralizumab for TED (Ref)
Roche’s Enspryng® (satralizumab; IL-6R inhibitor) received US FDA approval as the first and only at-home subcutaneous treatment for adults with thyroid eye disease (TED).The approval was based on Ph3, SatraGO-1 and SatraGO -2 studies. SatraGO-2 showed a significant reduction in proptosis and improvement in diplopia, with a favourable safety profile.
US FDA approved UCB’s zilucoplan autoinjector adults with gMG (Ref)
UCB’s ZILBRYSQ® (zilucoplan; macrocyclic peptide C5 inhibitor) received US FDA approval for self-administered via an autoinjector in adults with anti-AChR antibody positive generalized myasthenia gravis (gMG). The approval was supported by data from the Ph1, DV0012 and Ph3b DV0013 studies.
