On 12 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Amgen’s Uplizna® (Inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
Uplizna® has received previous approvals in other jurisdictions, including in the US (June 2020) and the EU (April 2022).
Inebilizumab was developed by Horizon Therapeutics before being acquired by Amgen in a $27.8 billion deal reached in December 2022.