Australian prescription medicine decision summaries

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.

We have approved Retevmo (selpercatinib) to treat adult patients with Non-Small Cell Lung Cancer (NSCLC).

We have provisionally approved Andexxa (andexanet alfa) for patients treated with a direct factor Xa inhibitor, when reversal of anticoagulation is needed.

We have approved Minjuvi (tafasitamab) to treat diffuse large B-cell lymphoma (DLBCL).

The medicine Imjudo (tremelimumab), in combination with durvalumab, is approved to treat adult patients with unresectable hepatocellular carcinoma (uHCC).

The medicine Tecvayli (teclistamab) has been approved by the TGA to treat multiple myeloma.

​TGA decision: Intrarosa (prasterone) is approved to treat vulvar and vaginal atrophy in postmenopausal women.

​TGA decision: Esperoct (turoctocog alfa pegol) is approved to treat haemophilia A.

TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with advanced or metastatic rearranged during transfection- fusion positive thyroid cancer.

TGA decision: Tibsovo (ivosidenib) is approved to treat cancer.

TGA decision: Teriparatide Lupin and LAPL and GH (teriparatide acetate) are approved for the treatment of osteoporosis.

TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with locally advanced or metastatic rearranged during transfection fusion-positive non-small cell lung cancer.

TGA decision: Jivi (damoctocog alfa pegol) is approved to treat adults and adolescents (12 years of age and older) with haemophilia A

TGA decision: Sunlenca (lenacapavir sodium) is approved to treat multidrug resistant HIV-1 infection.

TGA decision: Radicava (edaravone) is approved to treat adults with a diagnosis of amyotrophic lateral sclerosis.