On 7 February 2025, the Australian Therapeutic Goods Administration (TGA) approved UCB’s Rystiggo® (rozanolixizumab) in 140mg/mL solution for injection, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
In March 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Rystiggo® for the same indication.
On 31 January 2025, UCB announced that Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the self-administration of Rystiggo® via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional. Rystiggo® was approved as an add-on to standard therapy for adults with AChR or MusK antibody-positive gMG by the European Commission in January 2024 and by the US FDA in June 2023.