Australian Public Assessment Reports (AusPAR)

Wegovy (semaglutide) tablets are indicated for weight management in adults, as an adjunct to a reduced-energy diet and increased physical activity, and as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease, without established Type 1 or Type 2 diabetes. Concomitant use of WEGOVY (semaglutide) with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Coveram Plus SR is indicated as substitution therapy for treatment of hypertension, in patients already controlled with perindopril, amlodipine and indapamide, taken at the same dose level. Treatment should not be initiated with this combination.

Elahere (mirvetuximab soravtansine) approved for the treatment of adults with folate receptor-alpha (FRα) positive, platinum resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Qalsody (tofersen) has provisional approval in Australia for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

MS-2 Step Composite Pack (mifepristone and misoprostol) was approved in females of childbearing age for the medical termination of an intrauterine pregnancy up to 70 days of gestation and for the medical management of missed miscarriage up to 70 days of gestation.

Jaypirca (pirtobrutinib) is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Wainua (eplontersen) has been approved for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.

Fetroja (cefiderocol) has been approved for the treatment of infections due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options, including complicated urinary tract infections, pyelonephritis, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Hibruka has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision to approve this indication has been made on the basis of overall response rate (ORR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Exdensur is indicated as add-on maintenance treatment for inadequately controlled severe asthma in patients aged 12 and older with type 2 inflammation, and as an add-on therapy with intranasal corticosteroids for the treatment of adults with inadequately controlled CRSwNP

Cenrifki (tolebrutinib) is indicated in adults for the treatment of non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS) and to slow disability accumulation in the absence of relapse activity in adults with nrSPMS.

Zoladex (goserelin) has been approved for the management of oestrogen-receptor positive early and advanced breast cancer in pre- and peri-menopausal women.

Enflonsia (clesrovimab) is approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia should be used in accordance with official recommendations.

Zirdawny is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Tzield is indicated to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.

Redemplo (plozasiran sodium) has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate.

Slenyto (Melatonin) is approved to treat insomnia in children and adolescents with ASD, certain neurogenetic disorders (ages 2-18), or ADHD (ages 6-17) when sleep hygiene measures alone have not been effective.

Tabrecta (capmatinib) has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation.

Tuoyi (Zytorvi) is approved for the treatment of nasopharyngeal carcinoma.

Skyclarys has been approved for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Livdelzi (seladelpar) has been approved for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.

Filsuvez is approved for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Rhapsido (remibrutinib) has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.

Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. The use of this vaccine should be in accordance with official recommendations.

Zynlonta (loncastuximab tesirine) has been provisionally approved as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.