Australian Public Assessment Reports (AusPAR)

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.

Epyztek (ustekinumab) is approved for treatment of several conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive.

Ixifi (infliximab) is approved for treatment of several conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease, and ulcerative colitis.

Imdelltra (tarlatamab) has been provisionally approved for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Elfabrio (pegunigalsidase alfa) has been approved for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.

Lutathera has been approved for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults.

Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Lytgobi (futibatinib) has been approved for the treatment of locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Hepcludex (bulevirtide) is approved for treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.

Ospomyv, Xborso (denosumab) have been approved for the prevention and treatment of multiple bone-related pathologies.

Rapiblyk is indicated for short‑term control of supraventricular tachycardia and ventricular rate in atrial fibrillation/flutter, and for non‑compensatory sinus tachycardia in adults. Not for chronic use.

Augtyro has been approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Sondelbay, Teriparintas and Teriparaccord have been approved for the treatment of osteoporosis.

Opuviz, a bioisimilar to Eylea, has been approved for multiple eye-related conditions.

Anzupgo (delgocitinib) has been approved for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

Steqeyma (ustekinumab) has been approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, crohn's disease, and ulcerative colitis.

Osenvelt has been approved for the prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours. Stoboclo has been approved for the treatment of osteoporosis in postmenopausal women. Stoboclo significantly reduces the risk of vertebral, non-vertebral and hip fractures.