Rozanolixizumab is now available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of generalised myasthenia gravis. Myasthenia gravis is an autoimmune disorder characterised by fluctuating muscle weakness and fatigability.
Rozanolixizumab is a monoclonal antibody that blocks the neonatal Fc receptor (FcRn). FcRn normally protects immunoglobulin G (IgG) antibodies and albumin from intracellular degradation, thereby extending their circulating half-life. By preventing FcRn from salvaging and recycling IgG antibodies, rozanolixizumab promotes their lysosomal degradation. This rapidly reduces the levels of circulating IgG, including pathogenic autoantibodies.
Rozanolixizumab is administered as a subcutaneous infusion. In the Phase 3 MycarinG trial, patients were randomly assigned to receive weekly infusions of rozanolixizumab 7 mg/kg, rozanolixizumab 10 mg/kg, or placebo for six weeks. The primary efficacy endpoint was change from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Higher scores indicate greater disability and a reduction of at least 2 points is generally considered clinically meaningful. Mean reductions in MG-ADL score were greater with rozanolixizumab 7 mg/kg (-3.37) and 10 mg/kg (-3.40) than with placebo (-0.78).
The most commonly reported adverse effects were headache, diarrhoea, and pyrexia. While formal drug interaction studies have not been conducted, rozanolixizumab is expected to affect IgG-based therapies. If intravenous immunoglobulin (IVIg) or monoclonal antibody therapies are required, it is recommended that they be initiated at least two weeks after a rozanolixizumab infusion and that patients be monitored for reduced therapeutic efficacy.
Insulin degludec (Tresiba®) is now available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of type 1 diabetes mellitus.
Tresiba® is an ultra-long-acting basal insulin analogue with a duration of action of at least 42 hours. It is intended for once daily administration and may be given at any time of the day. While patients should be encouraged to administer doses at around the same time each day, the slow and consistent rate of absorption allows some dosing flexibility.
The SWITCH 1 and SWITCH 2 trials compared insulin degludec with insulin glargine (U100) in patients with type 1 and type 2 diabetes, respectively. Post hoc analysis of these trials found that improved glycaemic control increased hypoglycaemia risk regardless of the basal insulin used. However, for equivalent HbA1c reductions, degludec was associated with smaller increases in hypoglycaemia than glargine in both populations. These findings suggest that degludec may help patients achieve lower HbA1c targets with a lower risk of hypoglycaemia.
The PBS listing of degludec provides an additional basal insulin option for patients affected by the planned discontinuation of insulin detemir (Levemir®) from the Australian market later this year.
The Pharmaceutical Benefits Scheme (PBS) listing for acalabrutinib has been expanded to include the first-line treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in combination with venetoclax. Patients receive acalabrutinib monotherapy for the first two cycles, followed by combination therapy with venetoclax from cycle three.
Acalabrutinib is a second-generation Bruton’s tyrosine kinase (BTK) inhibitor. In B-cells, BTK signalling drives B-cell proliferation, trafficking, chemotaxis, and adhesion. Venetoclax is a selective inhibitor of B-cell lymphoma-2 (BCL-2), a protein that regulates apoptosis and is often overexpressed in CLL and SLL.
Both acalabrutinib and venetoclax are administered orally with a fixed dosing period of 14 cycles for this indication (where each cycle is 28 days). Acalabrutinib is taken twice daily, while venetoclax is taken daily from cycle three. A five-week ramp-up schedule is employed for venetoclax to gradually reduce tumour burden and lower the risk of tumour lysis syndrome.
The AMPLIFY trial was conducted in patients with untreated CLL. Combination therapy with acalabrutinib and venetoclax was associated with significantly prolonged progression-free survival compared with chemoimmunotherapy. Common adverse events included infection, neutropenia, and haemorrhage. Acalabrutinib has a more favourable cardiovascular safety profile than first-generation BTK inhibitors such as ibrutinib; however, hypertension and atrial fibrillation can still occur.
The Paxlovid® product information has recently been updated; it is no longer contraindicated in severe renal impairment.
Paxlovid® is an oral antiviral therapy for COVID-19 that contains nirmatrelvir co-packaged with ritonavir. Nirmatrelvir is a SARS-CoV-2 protease inhibitor that prevents viral replication, while ritonavir inhibits its hepatic metabolism. Co-administration is required to ensure plasma levels of nirmatrelvir reach the target therapeutic range.
When administered with ritonavir, renal excretion becomes the primary route of elimination for nirmatrelvir. Systemic exposure increases as renal function declines. A small open label study evaluated the safety of nirmatrelvir and ritonavir in patients with severe renal impairment. Findings suggest similar safety and efficacy to that observed in placebo-controlled trials that excluded patients with moderate to severe renal impairment.
No dose adjustment is required in mild renal impairment. However, dose reduction is recommended for patients with moderate and severe renal impairment, as outlined in Table 1.
Table 1. Recommended dose adjustments in renal impairment
| eGFR (mL/min/1.73m2) |
Nirmatrelvir |
Ritonavir |
Frequency |
| ≥60 |
300mg |
100mg |
12-hourly |
| ≥30 to <60 |
150mg |
100mg |
12-hourly |
| <30 |
300mg |
100mg |
Once on Day 1 |
| 150mg |
100mg |
Daily from Day 2 |
Abbrev: eGFR, estimated glomerular filtration ratePatients with severe renal impairment are at increased risk of severe COVID-19 outcomes, including hospitalisation and death. Therefore, access to appropriately dose-adjusted antiviral therapy is important. Patients receiving dose-adjusted Paxlovid® should be provided with clear dosing instructions and advised that the pack provided may contain more tablets than required for their course.
Fruquintinib has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of metastatic colorectal cancer. Eligibility requires that patients have either previously received, or are not suitable for, treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, as well as an anti-vascular endothelial growth factor (VEGF) agent and an anti-epidermal growth factor receptor (EGFR) agent for this condition.
Fruquintinib is a highly selective oral tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3. These receptors play an important role in angiogenesis associated with tumour growth and metastasis. The FRESCO-2 study investigated the efficacy and safety of fruquintinib in patients with heavily pretreated metastatic colorectal cancer. Fruquintinib was associated with significant and clinically meaningful benefit in overall survival (OS). Median OS was 7.4 months in the fruquintinib group and 4.8 months in the placebo group (HR 0.66; 95% CI 0.55-0.8; p<0.0001). Median progression-free survival was also improved (3.7 months vs 1.8 months; HR 0.32; 95% CI 0.27-0.39; p<0.0001).
Fruquintinib is administered once daily for the first 21 days of each 28-day cycle. Capsules should be swallowed whole and may be taken without regard to meals. Therapy is continued until disease progression or unacceptable toxicity occurs. Common adverse effects include fatigue, hypertension, stomatitis, diarrhoea, and hypothyroidism. Serious adverse events include haemorrhage and gastrointestinal perforation. In the FRESCO-2 study, asthenia was the most frequent reason for discontinuation.
A new indication has been added to the Wegovy® (semaglutide) product information. Provisional approval has been granted for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This condition (previously known as non-alcoholic steatohepatitis) is characterised by hepatic fat accumulation with inflammation and liver cell injury. Without effective management, MASH may progress to cirrhosis and hepatocellular carcinoma.
The goals of MASH management include weight loss (for overweight patients) and optimisation of blood pressure, blood glucose and lipid levels. Sustained weight loss of at least 10% is associated with particularly beneficial effects on disease activity.
This new indication is supported by positive results from the ESSENCE trial. In this double-blind study, patients with MASH and moderate or advanced liver fibrosis were randomly assigned to receive semaglutide 2.4 mg once weekly or placebo. After 72 weeks, 62.9% of patients in the semaglutide group achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared with 34.3% in the placebo group. A reduction in liver fibrosis with no worsening of steatohepatitis was reported in 36.8% of the semaglutide group and 22.4% the placebo group.
No new safety signals emerged, and the safety profile was consistent with the known effects of semaglutide. Gastrointestinal adverse events were the most commonly reported, including nausea, diarrhoea, and constipation.
Durvalumab is an immune checkpoint inhibitor that targets programmed death-ligand 1 (PD-L1), enhancing T-cell activation and anti-tumour immune responses. A new indication has recently been added to its product information, alongside an expansion of its Pharmaceutical Benefits Scheme (PBS) listing.
Durvalumab is now indicated for perioperative treatment of gastric and gastroesophageal junction cancer (GC/GOJC). This approval is based on positive results from the MATTERHORN trial, where the addition of durvalumab to standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) significantly improved event-free survival compared with chemotherapy alone.
From 1 April 2026, two additional clinical criteria were added to the PBS for durvalumab:
- Limited-stage small cell lung cancer (LS-SCLC) in patients whose disease has not progressed following platinum-based chemoradiation therapy.
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- This is the first immunotherapy to be PBS-listed in this setting and addresses a major unmet need, given the high relapse rates (~70% within five years).
- The listing is supported by results from the ADRIATIC trial, which demonstrated significant improvements in overall survival and progression-free survival with adjuvant durvalumab compared with placebo.
- Muscle invasive bladder cancer
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- The NIAGARA trial demonstrated that perioperative durvalumab plus neoadjuvant chemotherapy was associated with significant improvements in event-free survival and overall survival compared with neoadjuvant chemotherapy alone.
These developments highlight the expanding role of durvalumab across multiple tumour types and stages.
The Australian Technical Advisory Group on Immunisation (ATAGI) has released its clinical advice for influenza vaccination in 2026. Annual vaccination continues to be recommended for all people six months of age and older. A notable change this year is the introduction of a needle-free option.
FluMist® is a live attenuated influenza vaccine (LAIV) that is administered intranasally. It is indicated for use in children and adolescents between 2 and 17 years of age. Each pre-filled nasal applicator delivers two sprays, with one spray administered to each nostril. Children up to 8 years of age who have not previously been vaccinated against seasonal influenza are recommended to receive an additional dose four weeks later.
While this is the first year that an intranasal influenza vaccine has been available in Australia, they have been safely used in other countries since 2003. A recent meta-analysis found intranasal influenza vaccines to be comparable to injectable influenza vaccines for both safety and effectiveness.
On-going surveillance has not identified any cases of intranasal LAIVs causing influenza in vaccine recipients. However, FluMist® is contraindicated in moderate and severe immunodeficiency and children receiving salicylate therapy (due to the association of Reye’s syndrome with salicylates and wild-type influenza infection). The National Centre for Immunisation Research and Surveillance (NCIRS) recommends against administration to children with a runny or blocked nose as absorption may be affected. In these cases, vaccination may be deferred or an age‑appropriate injectable influenza vaccine considered.
FluMist® is available by private prescription and is also state funded for specific age groups in Queensland, New South Wales, South Australia, and Western Australia.
The Pharmaceutical Benefits Scheme (PBS) listing for ravulizumab has been expanded to include generalised myasthenia gravis (gMG). Myasthenia gravis is a chronic autoimmune disorder that affects postsynaptic acetylcholine receptors (AChR). Neuromuscular transmission is disrupted, causing weakness in voluntary muscles. To be eligible for PBS-subsidised therapy, patients must have a positive serology for AChR binding autoantibodies. It is thought that at least 80% of people with gMG have antibodies to AChR.
Ravulizumab is a terminal complement inhibitor. It binds with high affinity to complement protein C5 and prevents its cleavage to C5a and C5b. By inhibiting downstream complement activation, ravulizumab prevents formation of the membrane attack complex (MAC), a key driver of damage at the neuromuscular junction.
Ravulizumab is administered by intravenous infusion, with maintenance dosing every eight weeks. Its safety and efficacy in gMG were demonstrated in the double-blind, randomised CHAMPION MG study. Compared with placebo, ravulizumab produced rapid and clinically meaningful improvements in patient‐ and physician‐reported outcomes. During the open-label extension period (up to four years), these benefits were maintained in patients who continued ravulizumab. Patients who switched from placebo to ravulizumab experienced rapid improvements in activities of daily living, muscle strength, fatigue, and quality of life.
Although early steps of complement activation are preserved, ravulizumab increases the risk of infection, particularly with Neisseria species and other encapsulated bacteria. Life-threatening meningococcal infections have occurred during ravulizumab therapy. Patients should receive meningococcal vaccination at least two weeks before starting ravulizumab.
The Pharmaceutical Benefits Scheme (PBS) listing for incobotulinumtoxinA (Xeomin®) has expanded to include chronic sialorrhea.
Eligible patient groups include:
- Adults with Parkinson’s disease, atypical Parkinson’s, traumatic brain injury, or chronic sialorrhea following an acute event; and
- Children (2-17 years) with cerebral palsy, traumatic brain injury, or a developmental disorder.
Sialorrhea is commonly associated with neurological conditions and can cause social issues, skin irritation, and aspiration risk. Management typically requires a multi-modal approach. While anticholinergic medications may be effective in reducing saliva production, their use is often limited by adverse effects and drug interactions.
IncobotulinumtoxinA offers a targeted treatment option. When injected directly into the salivary glands, it reduces saliva production by inhibiting acetylcholine release from peripheral nerve endings. The onset of effect typically occurs within one week, with peak response at around four weeks. Dosing intervals are determined by individual clinical need but should not be more frequent than every 16 weeks.
IncobotulinumtoxinA has demonstrated efficacy in reducing unstimulated salivary flow rate. It is often better tolerated than systemic anticholinergics, particularly for patients with dementia or Parkinson’s disease who are sensitive to their effects on the central nervous system. Common adverse effects associated with incobotulinumtoxinA therapy include paraesthesia, dry mouth, and dysphagia. Severe and persistent dry mouth has been reported and may contribute to complications such as dysphagia or dental issues.
