We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Enspryng
Published
Product name
Enspryng
Active ingredient
Satralizumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Enspryng (satralizumab) was approved for the following therapeutic use:
Enspryng is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who have an anti-aquaporin 4 antibody (AQP4)-IgG (also termed NMO-IgG) positive status.
How this medicine works
Satralizumab is a humanised immunoglobulin G2 (IgG2) monoclonal antibody (mAb) that binds to soluble and membrane-bound human interleukin 6 (IL-6) receptor (IL-6R) and thereby prevents IL-6 downstream signalling through these receptors. IL-6 is a pleiotropic cytokine produced by a variety of cell types and is involved in diverse processes such as B-cell activation, differentiation of B-cells to plasmablasts and production of autoantibodies, T-helper 17 (Th17)-cell activation and differentiation, T-regulatory cell inhibition, and changes in blood-brain barrier permeability. IL-6 levels are increased in cerebrospinal fluid and serum of patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) during periods of disease activity. Some IL-6 functions have been implicated in the pathogenesis of NMO and NMOSD, including production of pathological autoantibodies against Aquaporin-4 (AQP4), a water channel protein mainly expressed by astrocytes in the central nervous system (CNS).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Enspryng was considered favourable for the therapeutic use approved.
Sponsor