Australian Public Assessment Reports (AusPAR)

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.

Niktimvo (axatilimab) has been approved for the treatment of chronic graft-versus host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older.

Orserdu monotherapy is indicated for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.

Tezspire has been approved as an add-on maintenance treatment in patients aged 12 years and older with severe asthma who are inadequately controlled despite optimal therapy including medium or high dose inhaled corticosteroids plus another non-steroidal medicinal product.

mNEXSPIKE XBB.1.5 COVID-19 Vaccine is indicated for: Active immunisation to prevent coronavirus disease 2019 (COVID-19)

Adzynma is a recombinant ADAMTS13 enzyme replacement therapy that has been approved for the treatment of ADAMTS13 deficiency in patients with congenital thrombotic thrombocytopenic purpura (cTTP).

Audenz (influenza virus haemagglutinin) is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.

Ekterly (sebetralstat) has been approved for the treatment of hereditary angioedema attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older.

Calcemic is indicated for active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older. Celldemic should be used in accordance with official recommendations.

Blenrep approved for the treatment of relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone in patients who have received prior therapy and in combination with pomalidomide and dexamethasone.

Alyftrek is indicated for the treatment of those who meet the diagnostic criteria for CF in people aged 6 years and older who have at least one mutation in the CFTR gene that is responsive based on clinical or in vitro evidence.

Dostiva and Dexeva are approved for preventing or managing cancer related bone complications and are biosimilars of Xgeva. Denolia and Deskeltia are approved for treating osteoporosis in men and postmenopausal women, as well as bone loss due to cancer therapies or long term glucocorticoid use and are biosimilars of Prolia.

Kavigale (sipavibart) has been approved for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments.

Briumvi (ublituximab) has been approved for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.

Andriga (abiraterone and prednisolone) has been approved for the treatment of prostate cancer.