The regulator adds new indications to the drug’s earlier approval for chronic plaque psoriasis.
UCB has announced that the TGA has granted marketing authorisation for bimekizumab (Bimzelx) for treatment of psoriatic arthritis and active radiographic and non-radiographic axial spondyloarthritis.
The approval was supported by results from the BE OPTIMAL and BE COMPLETE studies conducted in patients with PsA, and the BE MOBILE studies in axSpA patients, which were published last year.
“Having been involved in the bimekizumab clinical trial program, I am looking forward to the opportunity to prescribe bimekizumab in the real world for this expanded group of patients,” said rheumatologist Professor Stephen Hall in a statement.
“Adults living with psoriatic arthritis and axial spondyloarthritis often experience a range of severe symptoms affecting their quality of life, including swollen and stiff joints, chronic pain and irreversible structural damage,” said Professor Hall.
“The TGA registration of Bimzelx potentially provides a valuable new treatment option for patients.”
Bimekizumab was PBS listed for chronic plaque psoriasis from 1 October last year.
The TGA approval follows the March 2024 PBAC recommendation for PBS listing of the dual targeting L-17F/ IL-17A inhibitor for these indications.
Other recommendations from the March 2024 PBAC meeting included anifrolumab for lupus, avacopan for ANCA-associated vasculitis, a new form and strength of tofacitinib, and a new ustekinumab biosimilar for PsA and psoriasis.
See the full story on the PBAC outcomes here.
