Australian Public Assessment Reports (AusPAR)

Onakta (tirbanibulin) was approved for the topical field treatment of actinic keratosis of the face or scalp in adults.

Wegovy (semaglutide) was approved for weight management in obese adolescents ages 12 years and above (as an adjunct to a reduced-calorie diet and increased physical activity).

Wegovy (semaglutide) was approved as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults.

Xeljanz (tofacitinib) was approved for the treatment of ankylosing spondylitis and for active polyarticular course juvenile idiopathic arthritis.

Rinvoq (upadacitinib) was approved for the treatment of active non-radiographic axial spondyloarthritis in adults.

Nelarabine-reach (nelarabine) was approved to treat relapsing /refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Xenpozyme (olipudase alfa) was approved as an enzyme replacement therapy for the treatment of noncentral nervous system manifestations of acid sphingomyelinase deficiency in paediatric and adult patients with Niemann-Pick disease (types A/B or B).

Winlevi (clascoterone) has been approved to treat acne vulgaris in patients 12 years of age or older.

Sohonos (palovarotene) was approved to treat heterotopic ossification in individuals with fibrodysplasia ossificans progressiva.

Sidapvia (dapagliflozin+sitagliptin), a new drug combination, has been approved to treat type 2 diabetes mellitus in adults, as an adjunct to diet and exercise to improve glycaemic control.

Radicava (edaravone) was approved to treat adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.

Tevimbra (tislelizumab) has been approved for the treatment of oesophageal squamous cell carcinoma and non-small cell lung cancer.

Spy Agent Green (Indocyanine green) has been approved as an imaging agent for the fluorescence imaging of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts, lymph nodes and lymphatic vessels.

Yonsa Mpred (abiraterone acetate + methylprednisolone) has been approved for the treatment of metastatic castration resistant prostate cancer and metastatic hormone sensitive prostate cancer.

Koselugo (selumetinib sulfate) has been approved for the treatment of paediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Cibinqo (abrocitinib) has been approved for the treatment of moderate-to-severe atopic dermatitis in adults.

Tukysa (tucatinib) has been approved to be used in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2 positive unresectable or metastatic colorectal cancer.

Lynparza (olaparib) has been approved for the treatment of BRCA-mutated HER2-negative high risk early breast cancer and metastatic castration-resistant prostate cancer.

Jardiance (empagliflozin) has been approved for reducing the risk of kidney disease progression in adults with chronic kidney disease.

Heparin InterPharma (heparin sodium) has been approved for the prophylaxis and treatment of deep vein thrombosis in patients 18 years and older.

Hemgenix (etranacogene dezaparvovec), a gene therapy, has been approved for the treatment of haemophilia B (congenital factor IX deficiency) in adults.

Ultomiris (ravulizumab) has been approved for the treatment of adult patients with Neuromyelitis Optica Spectrum Disorder who are anti-aquaporin 4 antibody-positive.

Spevigo (spesolimab) has been approved for the treatment of generalised pustular psoriasis, a rare but severe form of psoriasis that involves flares of widespread, non-infectious, macroscopically visible pustules.

Givlaari (givosiran sodium) has been approved for the treatment of acute hepatic porphyria.

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