Australian prescription medicine decision summaries

Veoza (fezolinetant) has been approved for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.

Erwinase (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity to pegylated asparaginase obtained from E. coli.

Onbevzi (bevacizumab) is a biosimilar of Avastin. Onbevzi has been approved to treat a range of cancers either as a monotherapy or in combination with other anti-cancer medicines.

Wezlana (ustekinumab) has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Arexvy (recombinant respiratory syncytial virus pre-fusion F protein) is approved for individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus

Raniviz (ranibizumab) is approved to treat visual impairment issues.

Aquipta (atogepant) is approved for prophylaxis of migraine in adults

Givlaari (givosiran) is approved to treat acute hepatic porphyria.

Sohonos (palovarotene) is approved to reduce the formation of heterotopic ossification.

Beyfortus (nirsevimab) is approved for the prevention of respiratory syncytial virus (RSV) in neonates, infants and vulnerable children up to the age of 24 months.

Spevigo (spesolimab) is approved for the treatment of flares in adult patients with generalised pustular psoriasis.

Heparin Interpharma (heparin sodium) is approved for prophylaxis and treatment of deep vein thrombosis in patients 18 years and older.

Vafseo (vadadustat) is approved to treat anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.

Omvoh (mirikizumab) is approved to treat moderately to severely active ulcerative colitis.

Alhemo (concizumab) is approved to prevent haemophilia.

Tibsovo (ivosidenib) is approved to treat acute myeloid leukaemia that carries an IDH1 R132 mutation.

Vaxchora (vibrio cholerae) is approved to prevent disease caused by Vibrio cholerae serogroup O1 in those travelling to cholera-affected countries.

Vegzelma (bevacizumab) is approved to treat cancer.

Xenpozyme (olipudase alfa) is approved for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD).

Columvi (glofitamab) is provisionally approved to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Nurtec ODT (rimegepant (as sulfate)) is approved to treat migraine

Exarane (enoxaparin sodium) is approved to prevent and/or treat thromboembolic disorders, angina and non-Q-wave myocardial infarction and ST-segment Elevation Myocardial Infarction.

TGA decision: Tavneos (avacopan) is approved to treat adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).

TGA decision: Idefirix (imlifidase) has provisional approval for desensitisation treatment of adult kidney transplant candidates.

​TGA decision: Alhemo is approved where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B.