Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 1 min read
26/03/2026
UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG (Ref)
UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add-on therapy for adults with generalized myasthenia gravis who were anti-AChR antibody positive
DV0012/ NCT06511076 in healthy volunteers established zilucoplan bioequivalence between the pre-filled pen and pre-filled syringe, thereby confirming that the pre-filled pen might be an effective alternative for zilucoplan administration
DV0013/ NCT06471361 study in adults with gMG, showed that self-administration with the pre-filled pen achieved complete dose delivery in 99.8% of administrations, and was generally well tolerated
UCB planned to present these data at American Academy of Neurology (AAN) meeting, Chicago, Illinois, April 18-22, 2026
Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease (Ref)
Soligenix announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) had granted orphan drug designation to dusquetide (the active ingredient in SGX945; an innate defense regulator) for the treatment of patients with Behçet's Disease (BD)
The grant was based on recently published Phase 2a/ NCT06386744 results that demonstrated biological efficacy and safety in BD
